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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Medical device professionals know they must follow specific regulations — some of them even know what those regulations are. But how many professionals know how those regulations can help them be better designers and make their companies stronger?
In this discussion, we’ll talk about best practices for Design Controls and work towards truly understanding the reason for building a device. The speaker will discuss how to use that information to streamline the process from User Needs to Validation. There will also be a discussion about how to use design controls to mitigate risks within a product that might not have been previously recognized.
This event is brought to you by the RAPS Indiana Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.
Enterprise Member: Free
RAPS Members: Free
Regulatory professionals who are working with Product Development engineers. Product Development engineers who are new to Medical devices.
Learning Level: Beginner/intermediate
Content is: Beginner/intermediate
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation.
RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.
Etienne NicholsGreenlight Guru
Etienne Nichols is a medical device guru and mechanical engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startups to Fortune 500 companies and holds a project management professional (pmp) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the design controls process in a paper-based qms environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high-quality products to market.
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