2020 - Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection

Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
Firms MDR reporting and FDA's handling of reports
Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
Minimize your risk of regulatory enforcement actions
Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls
Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
Walk-through of case examples
Step-By-Step guide to designing Standard Operating Systems for communicating process for firm’s success
Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls