Medical Device Change(s), Analysis and 510(k) Impact 2013

Topics

• 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

Who should Attend

Attendees from medical device and combination products fields, including:

• Regulatory affairs
• Senior management
• Production
• Quality Assurance
• R&D and Engineering