Design Control Essentials for Medical Devices - Including Differences between ISO13485_2016 and FDA QSR _ eMedEvents

1. 10/13/21, 10:01 AM Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR | eMedEvents  Sign In Assistant Are you an Organizer?   SEARCH  Advance Search ‹ › Internal Medicine/Family MedicineOncologyRadiologyPsychiatryPediatricsEmergency MedicineNeurologyCardiologyDermatologyDentists Obstetrics and Gynecology Home / Conferences / Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR  Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR   By ComplianceOnline  Live WebinarOct 22, 202190 MinutesUSD 249.00 REGISTER  Overview Conference Summary Specialties Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR is organized by ComplianceOnline and will be held on Oct 22, 2021. Who Will Bene?t: • R&D Engineers • R&D Managers and Directors • Individuals participating in Product Design and Development • Individuals participating in design changes and failure investigations • Regulatory Affairs • Design Quality Engineers • R&D engineers and scientists • Compliance Specialists • Auditors • Senior Management Why Should You Attend: Design Controls are an integrated set of customer focused management practices to ensure quality and consistency. A rigorous Design Control process results in more predictable product development and improved quality and compliance results. And, if you’re selling medical devices in other countries, it is important to understand the differences between Design Control requirements found in FDA 21 CFR 820.30 and the requirements of ISO13485:2016 7.3 Design and Development. This webinar can help you create a design control process that is a competitive strength for your company and meet the expectations of different regulators. Description: Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the essentials of design controls for medical devices. Learning Objectives: • Understand regulations and expectations • 21 CFR 820.3 and ISO13485:2016 • Understand the Design Control Process • Identify key differences and solutions • Identify Best Practices • Prepare a Plan for Inspection Readiness Areas Covered in the Webinar: • Overview and De?nitions •DesignControlRegulations Target Audience Contact Us https://www.emedevents.com/online-cme-courses/live-webinar/design-control-essentials-for-medical-devices-including-differences-between-iso13485-2016-and-fda-qsr 1/3

2. 10/13/21, 10:01 AM Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR | eMedEvents • Design Control Regulations • Design Control Process • Planning • Design Inputs • Design Outputs • • Veri?cation • Validation • Design Review • Design Transfer • Design Changes • Design History File • Summary of differences between QSR and ISO13485:2016 • Linkages to other Quality System Requirements • Lessons Learned and Enforcement Case Studies • Best Practices • Preparing for an FDA or NB Inspection Specialties Healthcare Management Medical Education Target Audience Pharmaceutical Companies Contact Us Toll free Number 1(800) 828-2059 Email support@eMedEvents.com Chat Assistant Live Chat Reviews Given by People No Reviews available. Be the ?rst to write a review. Add Review Recommended Conferences Healthcare Management Medical Education Webcasts Live Webinar USD 299 USD 199   Oct 13, 2021 Human Error Investigations, Root Cause Determination and CAPA Effectiveness US FDA Medical Device QSR, 21 CFR 820 and Quality Management System Healthcare Management Medical Education, Quality Management Pharmacy and Medicine Live Webinar USD 229 Oct 18, 2021 Troubleshooting Dissolution Methods for Solid Oral Dosage Forms Pharmacy and Medicine, Medical Education https://www.emedevents.com/online-cme-courses/live-webinar/design-control-essentials-for-medical-devices-including-differences-between-iso13485-2016-and-fda-qsr 2/3

3. 10/13/21, 10:01 AM Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR | eMedEvents Subscribe for Newsletter, Medical News & Blog Updates Subscribe Your Email Address No spam, ever. Your email address will only ever be used for newsletter, medical news & blog updates Conference Organizer Services Marketing & Advertising Speakers Pharma Companies & Medical Device Manufacturers Marketplace Custom Pro?le List your Event for Free Event Marketing & Advertisement Event Listing Promote your Pro?le Advertisement Promote your Event Virtual Event Creation Publish your Work Email Campaign Targeted Marketing Talk to our Marketing Expert Online Event Hosting Network with Peers & Organizers Banner Advertising Data Mining Registration Widget Push Noti?cations Learning Management System (LMS) Search Engine Optimization (SEO) Payment Gateway Social Media Marketing (SMM) Accreditation Web Development Healthcare Professionals (Physicians, Nurses, Dentists..) Medical Resources Travel Deals Find CME/CE Events Online Courses CME Conferences 2021 CME Requirements by Country/ State Stays Free CME/CE Events Webinars CME Conferences 2022 Flights Initial Licensure Requirements Featured Events Webcasts CME Conferences 2023 Cars Medical Assessment Boards Popular Events Journal Based CME CME Conferences 2024 Specialty Certi?cation Boards In-Person Events Podcasts Events by Specialty - Online, In-Person, Hybrid Medical Societies by State Hybrid Events   Events by Location - City, State, Venue Medical Societies by Specialty Cruise Events Non CME Events Medical News Board Review Courses Company         Follow Us Download Our App About Us Blogs Privacy Policy Success Stories Pressroom Cookies Policy       Contact Us Terms & Conditions Copyrights © 2021 eMedEvents Corporation, All Rights Reserved. https://www.emedevents.com/online-cme-courses/live-webinar/design-control-essentials-for-medical-devices-including-differences-between-iso13485-2016-and-fda-qsr 3/3