Complaints, MDR & Adverse Reporting
Overview:
Complaint handling and reporting of adverse events related to the use of medical devices is a regulatory requirement in most regulated medical device markets. Yet the requirements are not the same, and the definition of ‘adverse event’ can even be different from market to market.
This course covers definitions (complaint, MDR, adverse event, investigation, etc), requirements for regulatory actions related to each, how to respond to a complaint that reports a possible adverse event, and how to report an adverse event to the regulatory authorities.
Instructional methods include: Lecture format, with questions/answers/discussion throughout.
How you will benefit:
By the end of the course, participants will have gained:
- How to identify if a customer report is a complaint and/or a reportable event
- What the requirements are for reporting – who, what, when, how
Course Topics:
- What is a complaint?
- What is an adverse event?
- What is an MDR?
- What are the regulatory requirements for complaints – in the US? In the rest of the world?
- What are the regulatory requirements for reports – in the US? In the rest of the world?
Who Should Attend:
Anyone who is involved in complaint handling and/or adverse event reporting: R&D, Mfg, RA/QA, sales/marketing personnel.