Maven 2021-2022 Magazine

1. Maven Profcon Services LLP LEADING CONSULTANCY IN THE MEDICAL DEVICE FRATERNITY Your expert guide

2. ABOUT MAVEN Maven is a regulatory affairs consultancy for Medical devices based in Ahmedabad, Gujarat, India currently staffing more than 25 employees with expertise in various aspects of medical device regulations and manufacturing. We offer an array of consultancy services including but not limited to, Preparation of technical documentation and other ancillary services for CE certification, Quality Management System, USFDA, NIOSH, Indian MDR, Clinical Trials and Annual Maintenance Services for medical device manufacturers. Based on the years of auditing experience of our founder, he could identify that manufacturers usually face difficulties in interpreting regulations, directives, guidelines, and standards and hence are unable to cater to the requirements of various notified bodies and authorities for certification. With that intention at heart, Maven was instituted to explore this niche sector here in India.

3. MISSION Maven Profcon Services LLP aims at delivering regulatory compliance guidance at a groundbreaking proficiency and leading the way for Regulatory conscious businesses in the medical device fraternity while helping customer’s unique experiences in regulatory consultancy. Our mission is driven by the thought of exploring a local business niche and provide easy access to international practices and serve the unmet needs of all Medical device manufacturers globally. VISION To be a pioneering, interactive, consumer-driven, and zealously referred, leading medical device consultancy with a dynamically evolving scope of regulatory services for catering to the needs of our customers and creating a large cliental of loyal customers. Our vision is to continue exploring global trends in Regulatory services, lead by example, and justify being MAVEN, by being the connoisseurs of medical device regulatory field. POLICY Maven Profcon Services LLP is engaged in providing the most accurate & best in time medical device consultancy with a closely knitted team. Customer commitment, Integrity, Optimum quality, confidentiality and the zest of leading are our core values. We offer an open-door policy to our employees where ideas and innovations are fostered into intangible assets and delivered to the clients. “We are a client relief organization, who happen to offer regulatory expertise”

4. LETTER FROM DIRECTOR As I look back to this incredible journey of last 6 years with Maven and my earlier experience of 5 years in the medical device industry, I see a profound change on how the medical devices are regulated across the globe. It is remarkable how much we have accomplished, not only in terms of financial performance but also in our unwavering dedication to help as manufacturers’ meet these complex requirements all over the globe. It gives me immense pride to convey that, Maven has become a preferred partner for more than 250 of its national as well as international clients, since its incorporation in 2016. For Indian manufacturers, we intend to help the clients meet and resonate with the global service standards whereas, for the foreign clients, Maven guides them with its industry acumen to comply with medical device regulations of various countries. We are well- acclaimed for its 100% client satisfaction rate where the customers are empowered by its regulatory acumen and implementation skills. From SMEs with a small workforce to well- established MNCs with thousands of employees, we have a clientele that encompasses both domestic as well as international clients. Irrespective of the size of the enterprises, Maven pays intense heed to every client’s complex requirements and is agile, responsive and proactive to resolve their regulatory grievances. Within a short period, Team MAVEN has attained a repute of being an assemblage of medical device regulatory experts and the elemental factor behind the thumping success of Maven Profcon Services LLP. Each teammate strives to foster groundbreaking services that could prove to be significant in the customer’s success. Our ingeniously passionate and result-driven professionals make MAVEN what it is today; granting new-age strategies and remarkable services to the global clientele. Our fairly performant team members possess vast expertise in regulatory consulting, auditing, medical device engineering, quality assurance, virtual and commercial business intelligence, and many with medical device industry experience in technical fields, that speaks volume in our favor. Lastly, I would like to thank all our clients for putting their faith and money in us and giving us the opportunity to help clear their regulatory hurdles. As we say at Maven “We are a client relief organization, who happen to offer regulatory expertise” and we will continue to scale up to our client expectations’ while retaining our core values and standing true to our Name, MAVEN- an expert or connoisseur.

5. You can do it. EVERYONE can do it! CEO OF THE YEAR AWARD 2021

8. PERFORMANCE HIGHLIGHTS As important, it is to consistently perform and deliver results, it is equally important to analyze and evaluate your performance regularly. We at, Maven have established our internal quality management system and place emphasis on analysis of our performance through feedbacks received from clients and employees, review of our internal processes, new emerging client requirements and actions taken to comply with them and also assessing risks arising from implementation of new systems and controlling them. It is through this system that we have been excelling on the number of projects we take up every year and the growth has been exponential. Our Director, who has always been adored by our employees as well as our clients, was recognized and awarded amongst the “CEO’S of the Year 2021” by a renowned magazine Business Connect which is just the beginning of our honorary journey. We are immensely proud to state that we successfully helped Welspun India and Control Print Limited outshine other 3-ply mask manufacturers by being one amongst a handful of manufacturers who have successfully received their 510k approvals. Furthermore, we were the first Indian organization to register one of our clients on EUDAMED and subsequently creating more than 20 EUDAMED registrations. As highlighted in the above chart, we have been actively working on multiple regulatory services ranging from preparation of customized individual documents to preparation of complete technical files. In continuation with the services that were already under our scope, we have also ensured that we achieved our target of adding new services as we do every year and this year Clinical trials, UDI, EUDAMED registration, Liability Insurance have played an exceptional role for us. With evolving trends and digital practices, Maven ensured to digitalize its services and assist their clients during times that were difficult to apprehend. From conducting digital internal audits (IQA), MRMs to preparing the entire technical file and uninterrupted support during external audits, we have not subjected our clients to face their regulatory grievances alone. With these services, we have also mushroomed our international presence and distance has no longer limited our potentials. Our performance management process and tools have helped us create and sustain in this niche work environment which values continuous improvement, adapts well to change, strives to attain ambitious goals, encourages creativity amongst the employees, promotes learning and professional development of the employees, and motivate employees to perform with aims for achievement of the organizational goals.

9. 12 QMS (21 CFR part 820, ISO 13485, ISO 9001) 5 NIOSH Projects 125 Free Sale Certificates 12 Country Registrations 10 New EU MDR Projects 7 US FDA 43 Clinical Writing 3 MDSAP 2 UKCA 4 20 EUDAMED Registrations Clinical Trials 21 AMC Clients 15 UDI 3 Indian MDR 6 Trainings

10. The Jedi of Maven Vaibhav Sharma R & D Head Ms. Indispensable Binal Kuntmal Head - Regulatory The Budding Star Shivani Patel Quality Assurance Manager The Powerhouse Mishika Jaiswal Head - Contract Management Ms. Beyond Expectations Khushboo Chhajer Head - Technical Sales

11. The Jedi of Maven Vaibhav Sharma R & D Head The Alpha Yogesh Dad Director The Powerhouse Mishika Jaiswal Head - Contract Management The Iron Pillar Maulik Patel Vice President

12. Clinical trials 01 EUDAMED registration 02 SERVICES ADDED 03 UDI Liability insurance 04 UKRP, Swiss Representative and US Agent 05 The medical device manufacturing industry is constantly growing due to developments in medical science and technology. Due to their impact on human life, medical devices are highly regulated. Not only that, but the list of products in scope of medical device regulations continues to expand as we better understand how certain substances affect the human body and simultaneously more stringent the requirements get. With evolving requirements, it only makes sense to grow our scope of services that sets us apart from similar services providers and adds to our expertise. Being a customer-centric organization and ensuring maximum customer engagement, we have successfully added so many new services to our bucket.

13. Clinical trials: With more and more innovative medical devices entering the market and increasing stringency on the high-risk devices, it is imperative to prove their clinical performance and safety for human-use. The old ways of proving such claims do not suffice any longer and have to be backed up with evident prospective or retrospective trials. We now can assist you accomplish these goals with a negligible involvement of your time and efforts. EUDAMED registration: It is obligatory for CE marked devices to have themselves registered on EUDAMED, which is a new requirement of EU MDR and is to be obliged by legacy device holder as well. Maven has ensured that the same has been done free of cost for all its AMC clients. All our new CE certification projects cover this service. UDI: Unique Device Identification which is again a new requirement imposed by EU. The notified bodies have been requesting manufacturers to provide the Basic UDI-DI and accordingly provide an updated DOC. The Basic UDI-DI is generated after using the pre-fix received from any of the 4 designated issuing entities. Maven exclusively provides the service of coordinating with these agencies on your be-half and takes care of generation of Basic UDI-DI and UDI-DI. To our AMC clients we even help generate the UDI-PI, which has to appear on every device label along with the UDI-DI. Liability insurance: EU Regulation indicates that medical device manufacturers are generally liable for all claims arising from one or any of their products and must therefore provide sufficient financial coverage proportionate to the risk class, type of device and the size of the enterprise. This can be addressed by having an adequate liability insurance in place and being your associates, we took it on our hands to find you best possible means to mitigate this requirement. We have spared our AMC clients the trouble of dealing with insurance companies directly and have successfully got them covered. UKRP, Swiss Representative and US Agent: Successfully managing our European Authorized Representative Services so far, we decided to expand our reach to different nations and bring to you our representatives in United Kingdom, Switzerland and United States of America.

14. MAVENS PRESENCE Maven is a Brand, a promise to its customer of its diversity and deliverables of its services and its exclusivity. We put strong emphasis on marketing our brand and to ensure we are exposing ourselves to a broader crowd and making them aware of our services, we take keen interest in visiting national and international exhibitions. Exhibitions that are targeted at business and people concerned about medical industry, welcome a diverse range of professionals and manufacturers and participating in these exhibitions enables us to have a face-to-face interaction with them. We run massive campaigns and schedule our appointments with those you are looking forward to regulatory support. It is during these exhibitions that manufacturers realize our brand relevancy and realize that we cannot be understated. Once they develop a sense of brand familiarity, they automatically connect with us. Even during the adverse Covid situation, Maven managed to attend the following National and International events: Medica 2021 Dusseldorf, Germany Arab Health 2022, Dubai IIME Expo 2021 Vizag, Vishakhapatnam In addition, we also look forward to meeting manufacturers’ at FIME - July 2022, Miami, USA and Hospitalar, May 2022, Sao Paulo, Brazil. We look forward to increase the numbers this year as we expand our sales & marketing activities and continue to meet with customers who are pro- actively looking for a deal.

15. CLIENT TESTIMONIALS Griportho Surgicals Pvt. Ltd. Mr. Dinesh Pokhariyal SIA Simurg Balticum Mr. Regimants Baranovskis We consider MAVEN PROFCON SERVICES LLP as an associate concern of Griportho and we have always counted on you for all our regulatory requirements. We shall always admire the way your support mechanism is in place with prompt responses & correct advices. I would like to appreciate level of service we’ve received from “Maven Profcon Services LLP” as highly professional, competent and proactive, maintaining agreed terms and at reasonable budget. Hardik International Mr. S.K. Rowther I just wanted to let you know that “Maven Profcon Services LLP” team has been doing a tremendous job in providing best consulting services in the filed of Medical Device. They are having a big team of qualified and experienced experts to coop up and fulfill all requirements of Medical Device Directives(MDD), We appreciative all their effort and engagement in providing us the right solutions for our all requirements. We wish them all the best for their all future assignments.

16. SPICTRA Sathish Kumar Head Manufacturing 1. What was the best thing about working with us? - The best thing about working with you so far was that you were been available for us any time as one of our company staff to provide immediate responses to the technical queries raised by our Notified Body without any hesitations 2. What results has our work generated for your company? - We have got re organized our technical file with the latest requirements of MDD which had resulted in getting the CE certification for 7 categories of our products without much difficulties in terms of compliance to the MDD. 3. What was your clients’ / the public reaction to our work? - The Notified body didn’t have experienced any difficulty in reviewing the file as it was compiled with all the relevant information and was organized in a clear and neat format. Pregna International Ltd Mr. Ranjit Gaikwad Ortho Max Mfg’ Co’ Pvt’ Ltd’ Mr. Pradeep Trivedi Maven Profcon Services LLP” has been very professional in their work with us at “Pregna International Ltd.” The Team was able to quickly grasp what we wanted to accomplish and had some great ideas on how to achieve our goals through 1st official MDR training. They have a wide variety of implementation scenarios in their background that they could draw information from the demo that they put together with great example was well received. It generated a lot of interest and knowledge for the upcoming Medical Device Regulation. We highly recommend “Maven Profcon Services LLP” for any type of Medical Device Regulatory Services. “I just wanted to let you know that your team has been doing a tremendous job on our request. They are turning things around quickly, coming up with approaches and suggestions on their own and are truly partnering with us on different initiative. We are deeply appreciative of all their effort and engagement.” I wanted to take this opportunity and appreciate the hard work Maven team has put in getting our CE certification. This was especially challenging given short turnaround time Meghdoot Pharma Mr. Hemant Koradia Maven have supported us during the time of our all regulatory needs, and that too with all the dedication and sincerity. Despite our several phone calls there has never been a voice of irritation from your side. Every problem was replied with absolute calmness and respect. Our best wishes for your vertical growth in this field.

17. EON Meditech Pvt Ltd . Nirav Khunt Technical Director We have been using your services since 2017 and very satisfied with services. Maven has helped us to get 2 CE certificates and update QMS according to the latest regulatory requirement. We are also working with other projects like CDSCO registration and get very positive support from your team. Working with Maven has been hassle-free and there were barely any followups required. The team has always efficiently & timely conveyed all the deliverables and made sure we provide data on time and kept us on our toes which we liked about them very much. Timely arrival of required certifications and therefore enhancing our business process This led to our clients being highly impressed by the efficiency & punctuality which resulted in the completion of the project on time without any turbulence. Keep up the wonderful work & strong ethics Sharma Pharmaceuticals Pvt. Ltd. Mr. D. K. Sharma Samay Surgical Mr. Mahesh Godhasara We are very glad to have Maven as our regulatory consultant or you may say regulatory partner, Maven has not only eased our process but always strive for process improvements with practical approach. Maven methodology & dedicated team for each project / client really helps in customer focus & valuable recommendations. The Maven team are ultimate rock stars! They are a highly professional, educated and experienced team that is dedicated to helping their clients achieve success. One of the best teams I have ever worked with – highly responsive, innovative and leverage best practices. From kick-off to project completion, they never miss a beat and are always there to answer questions and provide intelligent insight. They have been consulting for ISO 13485 and CE certification. They also provide Annual Contract facility for the same. Looking forward to many more projects ahead!”

18. Journey from 2021 to 2022

19. Journey from 2021 to 2022

20. MEET OUR HEADS Amongst many other indicators of organizations growth, Expansion plays a crucial role. When these initial signs of office expansion show up, it’s time to acquire an additional space and the same happened with us this year. Maven acquired an additional space and promoted the deserving candidates with individual cubicles. The Heads of various departments excelled their way through the thick and thin and rightfully won their seats. The office was inaugurated in August 2021 and has been resided by Mavens; finest. As man sows, so shall he reap! One must plant so that they can later harvest and with that at heart, Maven took its largest leap and created departments within the organization and hence diverging four deserving members of it family into Heads of four departments. This step is the foundation aligns to the vision of the director to see this organization flourish at a larger platform and has given a new direction to the organization where the best of each individual in their particular department will ensure that the organization as a whole will mushroom. This step puts our heads into challenging roles and bestows upon them a great responsibility of the organization’s future.

21. Perks of completing 5 years Every flourishing organization is backed up by a few people who have been constantly and effortlessly contributing to its growth. One of Mavens’ very own who has been with the organization for last 6 years now, since its foundation has very well deserved the company’s own policy of gratuity and we feel immense pride that Mr. Maulik Patel is the first of many to come. His sincerity, honesty and impartial judgement has helped stir Mavens’ boat in the right direction. His virtue and wisdom at many instances has helped make crucial decisions. We will continue to use his experience and skills.

22. EMPLOYEE WELFARES An organizations growth is impossible without the equal growth of its employees; hence, we consider employee welfare as an important investment. The physical, mental and emotional well-being of Maveniacs is crucial to our functioning and hence our work policies and fundamentals are built up around this. The physical work environment in the office is unusually friendly, open for communication, welcoming of new ideas and approachable. We do not intervene in an employee’s personal life, but when required by them we do provide necessary guidance and any kind or support needed with no questions asked. We have an open door policy for employee grievances, which are then analyzed by the management and appropriate corrective and preventive actions are taken to ensure optimum employee performance with the right mental attitude and healthier attitudes. We have also introduced a special process for employees to anonymously raise their concerns and book their slot for one on one discussion with the management and where necessary our director directly gets involved in solving their concerns. Bullying and harassment of employees is totally not acceptable at Maven and in the last 6 years we have not observed a single case of the same owing to the kind of work environment created here. The COVID-19 pandemic had affected employees’ welfare in our organization with more than 80% staff being infected severely, Maven ensured their well-being. Accommodation was arranged where needed, provision of other consumables was also personally ensured by our director. The organization had switched to remote working set-up until it was ensured that all employees had recovered from the ailment and its side effects. To ensure our employees have a good living standard outside the office as well, we have started with an incentive structure other than the regular salary. An incentive structure has been devised and documented for all the departments. Employees receive the same on basis of involvement in various activities. Maven respects employee loyalty and dedication and hence we have devised our very own generous gratuity system by awarding the employees with an incentive of 1% of the organization’s annual turnover. We wish that more and more of our employees benefit from this and be associated with us and grow with us for a long time.

23. This Trainings will help me gain more Knowledge I will plan my vacation from Compensation Leave. I am so happy with the Incentive Structure Maternity leaves are must now Pregnancy is a phase in life; many families expect it to happen to them soon. However, joyous and exciting the pregnancy is, for working women, the concerns prevail. A lot of apprehensions and dilemmas have led to many women employees missing their rightful share. Some women employees even quit jobs, as critical health does not allow them to continue working during the pregnancy period. We at Maven understand that many of our employees have moved away from their hometown to be associated with us and hence it is challenging to have help from home and thus we have initiated a maternity policy starting from this year, so that our female employees who make the majority of our team can benefit and take care of their newly born while also retaining their jobs. All work and no play makes Jack a dull boy and honestly, who even wants dull Jacks’ working with them. To ensure employees get enough time off from work and retain a healthy work-life balance, Maven has graciously initiated additional offs’ on alternate Saturdays other than the usual Sunday offs. We intend to keep our employees energized and refreshed and bring their best to work and to the client and at same time be able to manage their personal engagements. Furthermore, if an employee engages in any work related activities on these weekends, he/she is entitled to an additional leave. We recognize and reward the employee for the extra effort that he/she puts in, for the development of the organization. Employee trainings have always been the apex of our modus operandi and we have a well-established internal training system for all employees who get onboard with us. Medical device regulation is a dynamically evolving field and it is very important to stay updated. Maven has ensured that the employees are exposed and informed of these trends and hence we have participated in a lot of trainings and webinars. This year Maven looks forward to arranging multiple external trainings on the new emerging trends in medical device sector so that we can deliver the best to our clients.

24. EMPLOYEE DIARY Maulik Patel Vice President B.E. Electrical engineering and a total experience of 9 years and 6 years at Maven. Maven is not my job; it is my baby. From laying down its foundation to watching it grow has been a delight. We are envisioning a brilliant future for this organization and I shall continue to remain at its disposal. Mishika Jaiswal Head-Contract Management MS in Medical Devices from NIPER Ahmedabad I have been associated with Maven for the last 4 Years 9 Months and during this journey, being one of its initial employees, I have seen the passion and the hard work, Maven has invested to achieve its goals and to provide extended support to its customers in order to fulfill their requirements. I am very glad to be a part of Maven. Vaibhav Sharma Head - R&D BBA in Finance, PGDM in Banking & Financial Management, and a total experience of 4.5 years and 2.5 years at Maven. Maven is like a home for me, wherever I am or whatever I am doing, I cannot be away from Maven. Maven being the first stepping-stone in my professional life has completely changed my life. The growth & opportunities I have here go unmatched by any other employment I hold. Once a Maveniac, forever a Maveniac!

25. Binal Kuntmal Head-Regulatory Education: MS in Nanotechnology and a total experience of 5.5 years and 3.9 years at Maven. People say things like, “I didn’t realize how the time went.” However, I would say that I realized, in the most detailed manner, how the last 3.9 years of my professional life went with Maven. Because of the excellent employee support, infrastructure, liberal work culture, forward-thinking attitude, and tons of inspiration from our Director - Yogesh Dad, I have lived each day of my work life to its fullest! Maven offers many opportunities to learn, grow and prove your mettle in the regulatory affairs industry while working with clients worldwide. My journey from Jr. Regulatory Manager to Head Regulatory is a testament to everything I have said. Here at Maven, there is an ocean of possibilities; it all depends on how thirsty you are! Shivani Patel Quality Assurance Manager M.S. in Regulatory Affairs, Northeastern University-Boston and 2.7 years at Maven. I had some non-negotiable conditions- a company that inspires me, a field that I feel passionate about, a position that challenges me and stretches me into different areas, management that encourages and empowers me to do my best, and great work environment and team spirit. Maven fulfills all these points. For me, this is more than just a job. I am investing my time, my knowledge, and experience in a company that is investing in me. After two and half years of commitment, it is a real pleasure to still work with Maven and be a part of it. “This job is like a game...you have roads that can be shown to you, but no one can cross those roads for you and after each road, the level will rise.” Khushboo Chhajer Head-Technical Sales M.Sc. Biotechnology & and a total experience of 8 years and 2.5 years at Maven. When we’re looking for a job, we look for a culture we fit in, a space to learn and challenge our intellect each day, a place where our efforts make a real contribution to something greater than each individual. Coming from a diverse background of R& D and QC in IVD devices, Maven was a challenge for me even after more than 5 years of experience. I learnt, grew and excelled all while Maven showed it’s patience & acceptance of me. The sense of achievement is immense, and working here has brought me closer to my personal goals. Maven is a perfect amalgamation of modern work culture integrated with traditional values and personal connections that magnify collective and individual growth.

26. Jaydeep Satyani Client Manager Bachelor of Business Administration (B.B.A.) and a total experience of 5 years and 2.7 years at Maven. To me, a good job is not the job itself, with experience and skills, you can find a job that suits you but a good working environment is not that easy to find. Any organization can be a great place to work provided it offers required opportunities to its employees to show case their talent, learn new things, experiment new ideas and freedom to take calculated risks. YES, I see all this in MAVEN. I have been provided loads of opportunities, challenging & multi-tasking work, which has ultimately increased my knowledge & talent. Maven offers me the recognition of the hard work I do and offers me the support required. Here, I enjoy a lively work life with my dear, supportive and effective colleagues and their endless laughs. They make even crazy deadlines and massive workloads fun. I do not have colleagues, I have friends. Beloved ones. It’s true that, “Problems become opportunities when the right people come together” and lucky me, I found them all in Maven. Jigar Solanki Data Management Executive Bachelors in Computer Application and 1.2 years at Maven “I am glad to share that I have been associated with maven for more than 1 years now. The journey has been full of professional and personal growth. One thing that impresses me the most is the positive atmosphere and the importance maven gives to its employees. Every task completed imparts me with an experience and knowledge that helps me learn in the process. They consider each employee as an asset to the company and definitely know how to keep them happy and active”. Devki Patel Sr. Regulatory Executive M.S. in Regulatory Affairs, Northeastern University-Boston and total experience of 2.6 years at 1.2 years at Maven As a Regulatory Affairs, professional being able to see an idea retailored into a life-supporting product is in itself a learning experience. Maven has provided me a platform to inculcate challenges and mold myself into a more confident, determinant person and helps me suffice my thirst for knowledge. Maven is a family of team members where each person works towards achieving successful results and happy clients. Maven has been a stepping-stone to start my career as a Regulatory Affairs Professional and pursue my aspirations. I am thankful to this employee-friendly organization for giving me an opportunity to gain experience in every aspect of Regulatory Affairs. I hope someday, I will be able to return the kindness that everyone has shown, by working hard and contributing to taking this organization a step ahead.

27. Adarsh Jr. Regulatory Executive M.S. (Pharm) Medical Devices – NIPER Ahmedabad and 9 months at Maven. “I joined Maven right after my post-graduation. To work for an organization where the CEO himself is the youngest at heart is simply splendid! A “typical day” here is not typical by any means, there’s always an incredible potential for growth that presents itself on every passing day.” Prafullakumar Patil Jr. Regulatory Executive M.S. (Pharm) Medical Devices – NIPER Ahmedabad and 9 months at Maven. I joined MAVEN right after my post-graduation through NIPER campus placement. MAVEN is a great place for young, passionate, and creative minds to apply their skills and knowledge. Working in maven is fun, learning, and enjoyable at the same time. Team spirit, different brainstorming sessions, and work environment is keeping me more inspired. I am well versed in medical device development and Different regulatory strategies-Medical device. Sweety Evangeli Malli Jr. Regulatory Executive M.S. (Pharm) Medical Devices – NIPER Ahmedabad and 9 months at Maven. I feel very proud to be part of the organization as my career is growing with the growth of the company. The extraordinary knowledge obtained from the different types of projects with different team members has benefitted me a lot to learn multiple things in a little span of period. I am grateful to work in this company, which helps me grow every day to greater heights and provides an employee-friendly work environment that helps an employee to give quality work to the clients. In terms of career growth, it provides the best platform to enhance skills & knowledge. I feel this is the right place for fresher/experienced personnel to learn and to execute their thoughts where talent and hard work are recognized and appreciated. I thoroughly enjoy working with the team members in such a collaborative atmosphere and am happy to be a part of this organization.

28. Vishal Patel Administrative- Executive Bachelor of Business Administration (B.B.A.) and a total experience of 2.3 years and 8 months at Maven. I am glad to say that I joined Maven. I came to know about this organization from one of my friends who is my colleague as well. I saw good changes in his professional life and this inspired me to join Maven. The Director and all the leaders here are always helpful and I gained the best of the knowledge and skills here in a very short period. Supriya Kadam Sr. Regulatory Executive Master in Bio-Medical Engineering and total experience of 3.5 years and 7 months at Maven. Maven Profcon Services is a workplace where I get to learn new things every single day. The best part of the company is that the top management trusts the employees and the employee is groomed to become an expert. For me, this is more than a job. I am investing my time, my knowledge, and my experience in a company that is investing in me. Divyanshi Jethva Jr. Regulatory Executive Bachelor’s in Biomedical Engineering and 7 months at Maven. Getting a job in the field you studied in, is itself a wonderful thing, and if I must say getting your first job in such a wonderful company is a blessing in disguise and I believe it was a kick start to my career. This is truly a great place to work where I get the chance to learn, work, travel, and teach, in a collaborative and encouraging work environment that keeps us motivated. Every day provides an opportunity to learn something new, to mentor, and to be mentored. Being part of a team that is focused on helping our clients and fellow employees succeed, and that I feel is the best thing anyone could ask for in their career. What I have learned from working here is that the sky is the limit, and you can achieve anything, it depends on you. I am proud and humbled to be amongst such incredibly talented people and I am thankful for the opportunity to contribute to our continued success.

29. Tushar Poriya Jr. Regulatory Executive Bachelors in Pharmacy and total experience of 11 months and 4 months at Maven. “I joined Maven Profcon Services LLP in Dec 2021. The decision to join the orga- nization was highly driven by the strong vision of the organization. Over time, the organization has given me ample amount of opportunities to learn and grow as a professional as well as an individual. Top management and the team around have always been approachable. A combination of work-life balance and friendly work culture has made this organization an ideal example for any employee who would look for”. Sakshi Sindhwani Jr. Regulatory Executive P.G. Diploma in Regulatory affairs and 2 months at Maven “Working for a service that truly values their employee as individuals and supports each person to achieve their individual goals, both professionally and personally! Maven is a place for learning, exploring, and growing stronger. I previously worked as Microbiologist and QA coordinator in Medical. Connecting my Experience, Edu- cation, and technical skills to the company would be an eminent opportuneness. Seeking many more years of exploring. I wish this journey would be remarkable forever!” Ravi Pitroda Sr. Digital Marketing Executive Master Of Computer Application and Total experience of 5.9 years and Just join at Maven I have been associate with Maven from its beginning as a freelancer but Now I had the opportunity to work with them as a full time member. I had seen the growth of Maven and very well know how supportive management is. Lucky to be a part of Team Maven

32. PROCESS ENHANCEMENTS To enhance the quality of services, customer satisfaction, customer loyalty, increased productivity, development of the skills of employees, efficiency and faster turnaround time, Maven proactively identifies, analyzes, and improves its existing business processes. Different systematic approaches have been considered and emphasis has been made on project management, time management, automation, and keeping clients updated with the project progress. Project Management-Salesforce To address the basic need of tracking the on-going tasks and collaborating with team for project information and developments, we customized the world’s go to software, SALESFORCE to suit our processes. With the idea of our growing needs and our team out-growing the basic project management tools and to merge all our processes and systems at one destination, salesforce was born. Our project management tool provides us seamless integration, flexibility, real-time reporting, and automation. AMC Dashboard- Data Studio Maven is the only India based consultancy that offers an Annual Maintenance Contract services to medical device manufacturers for maintaining their regulatory documentation and certifications. Mavens’ uniquely designed and customized AMC plans have helped many manufacturers’ maintain their quality management systems, ensure continual compliances, enhance employee competency and support internal and external audits. To keep our clients updated on activities that go around their AMCs and upcoming audits, status of their organizations performance, we have recently launched a dashboard, which can be accessed by the Top management anywhere and anytime. We have also initiated monthly trainings for our AMC clients on various medical device related topics that could either help them in their manufacturing related aspects or keep them updated of the regulatory trends. These monthly trainings are conducted as per the annual training Calendar and the participants are awarded certification for the same.

33. MAVEN- Quality Management System Charity begins at Home. While we address the needs of process and documentation control for hundreds of manufacturers’, we are also in the process of developing our in-house procedures and work instructions. These procedures shall ensure that the documents be prepared in a particular format with attention to the minute details and shall demonstrate the minimum requirements of the applicable standard/regulation. These SOPs shall be accessible to all employees at any given time to prepare complaint documents and hence reduces the time that goes in brain storming every time before preparing the same documents and ensures minimum non-conformities. The procedures shall be prepared on the basis or requirements and years of experience in this sector. Monthly and weekly status reports to client When one invests money to outsource their needs, it is very important that they be updated on how every penny of it is being utilized and we at Maven understand this. With that in mind, we have initiated the trend of sending our clients project status reports. For regular projects, an index with the status of documents and further course of action planned is sent to the client and for the AMC clients, a monthly status report is sent. A monthly follow-up is also sent to AMC Client for PMS data and other data requested in the visit reports. MAVEN Quality Management System Monthly and weekly status reports to client Project Management Salesforce AMC Dashboard Data Studio

34. SHAPING THE FUTURE OF REGULATORY COMPLIANCES It is easy to achieve success; it is difficult to maintain it. To become successful in anything, one must put in more hard work than others, have self-discipline, make sacrifices and clear goals based on well-defined values. Maven has always believed in all these fundamentals and will continue sticking to it for the future. We believe we have just started and our vision of the company’s future keeps expanding as we grow and with our growth, we intend to bring innovation in the field of regulatory affairs to help medical device manufacturers. Live Project tracking Maven has already implemented Salesforce for its project management and tracking of these projects for its internal calibration but we also plan to give its access to our clients to track their project live and this year we shall be exclusively working on making this happen. This is intended to not only cater to the curiosity of client on project progress but also to keep them informed on what information has been requested and is pending from their end and hence what activities are being affected or delayed. The live project tracking will also enable them to see things in action and understand that how much time is being invested in curating the best of documents for them. Automation in Quality Management System and maintenance of Technical documentation Process automation streamlines a system by removing human inputs, which decreases errors; increases speed of delivery, boosts quality, minimizes costs, and simplifies the business process, which is exactly what every business needs. Maven has been actively brainstorming and has put its best minds at work to bring forth some automation that could help address these concerns for all medical device manufacturers. Alliances It is our intention to become a one-stop solution for all regulatory requirements and hence it becomes obligatory to search, analyze, evaluate and join hands with the best in diverse fields. We already have alliances for European Authorized Representative Services, US Agent services, CRO’s, Swiss Representative, United Kingdom’s Responsible Person, UDI Services, Liability insurance services and many testing laboratories. This year we will mainly focus on expanding our connections with a range of testing laboratories covering different testing applicable to different medical devices. The major objective in the coming year is our collaboration with notified bodies covering various MD codes. This alliance will completely modify customer experience and expedite the process of certifications.

35. On the occasion of our 6th anniversary (1st April 2022), we are launching RegXpert- Learn from the Regulatory experts, our newsletter and blog hub. This will be where Maven will pour out all its knowledge on regulatory requirements and updates to keep our readers avid. Any updates on trainings, events in Maven and any other information deemed appropriate to be conveyed shall all be found here. Hello Maven! Sometimes it is not possible to reach all the people who require our support, and other times many manufacturer are stuck at one or two requirements and might require an easy and quick fix. We are aiming to start an online helpline where manufacturers or any other person would be able to call and seek for regulatory advice on hourly basis. We aim to help all those who either have small obstacles or hurdles or are seeking re-confirmation. Office expansions: We are pleased to inform that starting early next year, we are shifting to a larger premise, which is twice the size we are currently residing and will be state of art facility. We are aiming to become a team of 50 regulatory professionals at your service by the start of the year 2023. We aim to design this office with careful consideration and with eye for minute details to ensure employee comfort. Mavens’ presence in 2023 This year we look forward to attending major medical device exhibitions at a national and international level. The most recognized events that attract global manufacturer’s like FIME, MEDICA, ARAB HEALTH, HOSPITAL R and many other national events. We intend to reach out to masses and resolve their regulatory grievances. Maven was, is and will always be a client relief organization and will try everything in its capacity to remain at the disposal of our clients. Your support brought us success in 21-22! We continue to look forward to strengthening our bonds in this new financial year

36. CONTACT US Our innovative passionate and result-driven professionals make MAVEN what it is today; providing modern approaches and remarkable service to clients all over the globe. VISIT US 1120-1121, Sun Avenue One, Near Sun Prima, Ambawadi, Ahmedabad – 380006, Gujarat, India. WRITE US CALL US 079-40026222 079-40046222 +917490017774 business@mavenprofserv.com www.mavenprofserv.com 09:30 AM TO 06:30 PM FOLLOW US ON