Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices 2015 is a webinar that covers topics such as:
- Test selection of the ISO standard
- Background of the new draft guidance
- General biocompatibility testing considerations
- Test selection as per the FDA modified matrix
- Labeling
- Test specific considerations
- Examples
- Test Reports
- Comparison of the draft guidance with the 1995 memorandum
Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices 2015 is intended for:
- Project managers
- Regulatory managers
- Product development managers
- Staff involved with regulatory filings
