Medical Device Change(s), Analysis and 510(k) Impact 2013 is a webinar that covers topics such as:
- Expected sources of information for evaluation and inclusion
- Current Requirements of the K 97-1 Memorandum, and FDA Expectations
- Change reporting "tipping point" -- with one change or cumulative
- Two approaches to the use of FDA`s K97-1 Memo
- Which of the three major 510(k) formats should be used
- Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes
- How to complete, document and control as a `living` document
Medical Device Change(s), Analysis and 510(k) Impact 2013 is intended for attendees from medical device and combination products fields, including:
- Regulatory affairs
- Senior management
- Production
- Quality Assurance
- R&D and Engineering
