As a domestic or foreign medical device manufacturer including an importer and user facility, you are subject to regulatory requirements for complaint handling and medical device reporting (MDR) in the US.
FDA frequently cites in 483s upon establishment inspections and subsequently warning letters issued to the firms as follows.
“…Your failure to establish and maintain adequate complaint handling or medical device reporting procedures…”
This presentation is intended to help global medical device firms and stakeholders adequately implement US FDA-compliant medical device complaint handling and medical device reporting (MDR) systems. Even if it is believed that the similar or relevant procedures have been implemented in your firms, it is time to ensure all aspects of the requirements are under check to be adequate and compliant. To achieve compliance and to remain compliant with the FDA-compliant complaint handling and medical device reporting, it is imperative that the firms accurately understand, interpret, and implement the requirements for handling all complaints (electronic, written, or ORAL) and medical device reporting to be better sustainable as evident from a recent case.
In this 60-min presentation, the speaker will guide you through the details of the required elements to successfully implement the medical device complaint handling and medical device reporting systems so that you can ensure your firms adequately establish and maintain the applicable systems in a PASS-IT manner.
Areas to be Covered:
Applicable Laws and Regulations
Requirements for Complaint Handling
Requirements for Medical Device Reporting
Applicable Processes and Procedures
Key Elements in the Procedures: Complaint Handling and MDR
What to Do When a Complaint Is Received
What/How/When to Investigate a Complaint
Complaints Investigation and Documentation
Medical Device Reporting
How to Determine Reportable Events
Establishing Reportability Criteria
Additional Documentation Requirements for MDR
Mistakes and How to Avoid Mistakes and 483s
Relationships between Complaint Handling, MDR, and CAPA
Enforcement Case Studies
Improving Our Awareness and Continuous Improvement
Speaker’s PASS-IT suggestions and recommendations
Who will Benefit:
R&D engineers and scientists, managers, directors, VPs
Compliance and Legal Affairs
Auditors and Consultants
Anyone Interested in Medical Device Complaint Handling Systems