Course Description
As users and regulatory agencies are becoming less ‘tolerant’ of medical device failure, regulatory agencies are placing greater emphasis on post market surveillance as a way to improve risk management and protect public health. This course will review the regulatory expectations for post market surveillance and outline how to apply the requirements to medical devices. Topics include: complaint handling & vigilance systems, Medical Device Reports (MDR), implementation challenges, medical device tracking, impact of post approval studies, compliance requirements & meeting them, and complaint systems inspections.
Throughout the course, examples and case studies will help participants apply the concepts being covered.
Who Should Attend
This course will be of great value to medical device professionals involved in post market surveillance/complaint handling. It is primarily designed to benefit the following disciplines and personnel:
- Post Market Surveillance
- Complaint Assessment & Handling
- Quality Assurance
- QMS & Compliance Management
- Risk Management
- Regulatory Affairs
- Clinical Affairs
- Medical Directors
- Manufacturing
- Research and Development
- Recall Coordinators
Learning Objectives
By the end of this course, participants will:
- Know the requirements of post market surveillance
- Understand the similarities & differences between FDA & EU requirements
- Know the requirements for compliant & effective complaint handling
- Understand the differences between feedback, complaints & reportable events
- Know how post approval studies impact post market surveillance requirements
- Understand the compliance requirements & practical needs for medical device tracking
- Understand how Quality System requirements are linked to post market surveillance
- Understand the importance of decision making, escalation & timeliness
- Understand the challenges of implementing a compliant & effective complaint handling system
Course Locations
