FDA & ISO Requirements for Medical Devices
Medical device design engineers, manufacturing engineers, and quality engineers will gain a valuable understanding of FDA requirements, which will be compared to ISO requirements. Understand the need for regulations for medical devices and gain valuable insights to make your products compliant and fail safe.
Dr. Terry Layton has 40 years of experience in the medical device industry. He is a technical executive with strong background in building medical device manufacturing companies. His diverse experience includes industry and consulting work in product development, regulatory/QA, operations, IP, ... read more
Benefits and Learning Outcomes
- Understand the FDA requirements and how they compare with ISO requirements
- Learn what guidance documents are and why they matter
- Explore why regulations are necessary
- Engage in group exercises to gain practical insights.
- 21CFR800 & 820
- Design Control
- Quality System Regulations
2.FDA v ISO
- Device Classifications
- Clearances or Approvals
- Safe & Effective Products
- Substantially Equivalent
- PRD & Predicate
- Test & Measurements
Session will include lectures, Q&A and group/individual exercises
Dates and locations to be announced.