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.
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
All sessions are Face-to-Face unless otherwise noted.