Course description
Post-Market Surveillance and Vigilance for Medical Devices
This Masterclass is also Module 16 of the MSc Regulatory Affairs and will help to define the terminology and explain the concepts of vigilance and post-market surveillance, their practical applications and integration into the lifecycle of a medical device. This course will focus on meeting European requirements.
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Suitability - Who should attend?
This course is suitable for
- Students of the TOPRA MSc programme
- participants from the regulatory affairs industry who wish to develop their knowledge of the post market surveillance and vigilance for medical devices
- participants from allied industries who wish to have a comprehensive understanding of the subject
Outcome / Qualification etc.
Benefits to participants
- Be able to critically appraise a PMS system and make recommendations on the implementation of a PMS system
- Be able to make recommendations and vigilance procedures
- Demonstrate the ability to critically analyse the legal requirements relating to surveillance and vigilance
- Critically appraise and evaluate communications from competent authorities, notified bodies, economic operators and other stakeholders relating to the conduct of surveillance and vigilance.
- Critically evaluate the requirements and guidance for post-market market surveillance
- Critically evaluate the requirements and guidance and vigilance
- Possess a systematic understanding and critical awareness of the European requirements including legislation, guidance and associated documentation relating to surveillance and vigilance for medical devices.
- Be able to critically appraise a PMS system and make recommendations on the implementation of a PMS system
Training Course Content
The Masterclass will cover the following areas:
- European Regulatory requirements for PMS, including recalls and vigilance
- Responsibility for PMS: Competent Authorities, Notified Bodies, manufacturers and other economic operators
- Other Regulatory requirements – e.g. US MDRs
- Guidance documents for PMS, including Commission, Notified Body and Competent Authority documents
- Key elements of pro-active PMS including PMS system and PMS plan,
- Role of the person responsible for regulatory compliance in PMS
- Tailoring PMS systems to specific products, including drug device combinations and IVDs
- Requirements of EN ISO13485, Quality Management Systems standard
- Feedback of PMS data into the PMS plan, risk management, clinical evaluation, summary of safety and clinical performance, labelling and so on
- PMS reports and periodic safety update reports (PSUR’s)
- Vigilance including incidents, serious incidents, field safety corrective actions,periodic summary reports and trend reports
- The electronic system on vigilance and PMS including public access
- Exchange of information: PMS databases e.g. MAUDE and EUDAMED
Expenses
The full tuition price for students is 1500 GBP. The price for participants is 1700 GBP
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