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Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic – Learn what FDA is really thinking on regulation and guidance documents
February 18 @ 10:00 am - February 19 @ 4:00 pm UTC-5
Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.
By attending this seminar, you will discover:
- How to overcome one of the biggest obstacles device manufacturers face
- How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
- How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
- How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.