Medical Device Change(s) and 510(k) Submissions - Webinar By ComplianceOnline (Medical Devices)
Venue: Online Event
|Event Date/Time: Jul 26, 2011||End Date/Time: Jul 26, 2011|
Control of medical device changes and a current 510(k) are big issues in recent FDA studies. The FDA expects companies to perform meaningful, results driven 510(k) / change analysis activities, and may soon mandate more rigorous reporting.
Companies are held fully responsible for deciding when a new 510(k) filing is warranted. Growing high-profile field problems indicate that change control and its effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis . A growing push by the Agency to strengthen the 510(k) process in the U.S. is one result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised.
Areas Covered in the Seminar:
- Key requirements of the three types of 510(k)s.
- Fully capture your device change control process.
- Expected sources of information for evaluation and inclusion.
- Two approaches to the use of FDA's K97-1 Memo.
- Step-by-step analysis.
Change reporting "tipping point" -- with one change or cumulative.
- Which of the three major 510(k) formats should be used.
The employees who will benefit include:
- Senior management
- Regulatory affairs
- Quality Assurance
NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.