medical device regulatory consulting services – operon strategist

2. About Operon Strategist Operon Strategist provides technical consultancy & regulatory consultancy services to healthcare industries. We also provide Guidance to various manufacturers and provide services like turnkey services, complete turnkey solution, system implementation, training, licensing, regulatory approvals and certifications. Operon Strategist has a team of experts whose knowledge & experience helps them to handle all client requirements.

3. Services Operon Strategist provide services in two categories: 1. Medical Device Industry 2. Primary Packaging Material Industry

4. 1.Medical Device Turnkey Project Consultant: Turnkey Project is an aggregate turnkey way to deal with their medical device project. In Medical Device Turnkey Project Management we reduce the client’s costs and the effort for observing, individual coordination and planning to minimum. We are responsible for complete technical coordination of Turnkey Device. We provide a complete package of turnkey services including Layout Design, Clean Room Design , Validation, Developing Quality System, Documentation, Training & Implementation Services

5. 1. Layout Design: Layout Designing is important factor which helps to determine space requirement for various processes and their respective machinery. We design layout in such a way to ensure that unidirectional flow of man and material which helps to prevent cross-contamination 2. Clean Room Design: Clean Room is create to maintain for sterilization of medical devices for that have to maintain low level of bio-burden for effective sterilization. Operon Strategist help in establishing clean Room with low level bio burden & sterility according to US FED STD 209E clean room standards. 3. Process Validation: Validation Process is important validation documentation for cGMP requirement and also for regulatory agencies. which help to proved that manufacturing product having consistent quality and fulfil all required level of compliance at every stage. Operon Strategist guides manufactures and validation service providers about validation activity and documents.

6. 2.Primary Packaging Turnkey Project Consultant  Primary Packaging Material is material that may or may not be in direct contact with the dosage form. Primary packaging may comprise any single part of a container closure system including containers, container liners, closures, closure liners, stopper oversells, etc. Operon Strategist provide guidance about primary packaging material. 1. Facility/Plant Layout Design For Primary Packaging :Layout Designing is important factor which helps to determine space requirement for various processes and their respective machinery. We design layout for primary packaging in such a way to ensure that unidirectional flow of man and material which helps to prevent cross- contamination 2. Clean room conceptualization For Primary Packaging: Clean Room is create to maintain for sterilization of medical devices for that have to maintain low level of bio-burden for effective sterilization. Operon Strategist help in establishing clean Room with low level bio burden & sterility according to US FED STD 209E clean room standards.

7. 3. Process Validation For Primary Packaging: Validation Process is important validation documentation for cGMP requirement and also for regulatory agencies. which help to proved that manufacturing product having consistent quality and fulfil all required level of compliance at every stage. Operon Strategist guides manufactures and validation service providers about validation activity and documents.

8. 3. Medical Device Certification Consultant:  For medical Devices different country having different market approach for market clearance & sale of medical devices. Each Medical device varies in size, ease of use, safety ranging from simple bandages, surgical instruments to implants & complex systems involving software. So for this we provide guidance to manufacturing company about different requirement for different product certification. The regulatory requirement vary according to risk of the product & intended use.

9.  We Provide different Regulatory & Certification Services For Medical Device Manufacturers: 1. ISO 13485 Certification Consultant: For Quality Management system(QMS) of Medical Devices & related services. 2. USFDA Certification Consultant: Required for supplies product in USA 3. CE Mark Certification Consultant: Helps to declares that a product meets the EC directives. 4. CE Technical File or Design Dossier Compilation and Review 5. 510(k) Certification Consultant & Regulatory Guideline For Medical Devices : premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective 6. TGA & ANVISA Regulatory Affairs For Medical Devices: Regulatory body which Conducting assessment & monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard. 7. CDSCO Regulatory For Import License & Wholesale Registration: National regulatory body for Indian pharmaceuticals and medical devices.

10. 4. Design & Development- Combination Products  Manufacturer of Medical devices and combination products shall have adequate design and development which prove that safety and efficacy of the product. Operon Strategist provide design and development guidance for medical devices and for combination products according to ISO 13485: 2016 and 21 CFR Part 820.