Short course/CPD
Medical Device Vigilance, Post-Market Surveillance (PMS) and Risk Management
Course date: 11 Sep 2012 - 13 Sep 2012
Course overview
The course will define the terminology and explain the concepts of vigilance, post-market surveillance and risk management, their practical applications and integration into the lifecycle of a medical device.
Location
Mitchell Hall, Cranfield campus. Bedfordshire. MK43 0AL
Course fee:
£1,300.00
(includes refreshments at coffee breaks and buffet lunch)
Accommodation fee:
Accommodation available if required. Please enquire for details.
How to register
To book a place on this course please return the booking form to:
Lesley Roff
Academic Operations Unit
Cranfield University
Bedford MK43 0AL
T: + 44 (0) 1234 754192
+ 44 (0) 1234 754193
F: + 44 (0) 1234 751206
E: shortcourse@cranfield.ac.uk
Accreditation
This course has been developed with and is accredited by TOPRA, The Organisation for Professionals in Regulatory Affairs
Course description
The course content covers:
- European Regulatory requirements for PMS, including recalls and vigilance
- Responsibility for PMS: Competent Authorities, Notified Bodies and manufacturers
- Other Regulatory requirements – e.g. US MDRs
- Guidance documents for PMS, including Commission, Notified Body and Competent Authority documents
- Key elements of PMS – reactive and pro-active
- Tailoring PMS systems to specific products, including IVDs
- Principles of ISO 14971 “Application of risk management to medical devices”
- Requirements of ISO13485, Quality Management Systems standard
- Feedback of PMS data into the risk management process
- Exchange of information: PMS databases e.g. MAUDE and EUDAMED
- GHTF Study Group II
Who should attend?
Regulatory affairs professionals.
Course format
2.5 days including lectures and practical sessions
The course is also Module 5 of Medical Technology Regulatory Affairs MSc.
