INTRODUCTION
Post market surveillance is an effective tool to handle crisis management and control public health. The lessening credibility of the medical devices by the consumers and regulatory agencies has led to the popularity of post market surveillance. This course will be focusing on the regulatory expectations for post market surveillance and explain the methods of applying the requirements to medical devices.
PROGRAM OBJECTIVES
- Topics consist of handling complaints
- Complaint systems inspections surveillancs systems
- Medical Device Reports (MDR)
- Implementation challenges
- Medical device tracking
- Impact of post approval studies and fulfilling compliance requirements.
WHO SHOULD ATTEND?
- Recall Coordinators
- Research and Development
- Manufacturing
- Medical Directors
- Clinical Affairs
- Regulatory Affairs
- Risk Management
- QMS & Compliance Management
- Quality Assurance
- Complaint Assessment & Handling
- Post Market Surveillance
PROGRAM OUTLINE
- Definition of Post Market Surveillance
- Terminology: surveillance, complaint, adverse event...
- Lifespan of a medical instrument
- Importance of risk assessment and risk management
- Medical device design and manufacture:
- Relationships with surveillance & complaint handling
- Requirements for approval & post approval studies
- Adverse event & vigilance reporting
- Definition of a medical device report
- GHTF SG2 guidelines
Permintaan Brosur penawaran Training
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