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.
At a glance
- 11 - 13 Sep 2018
- Duration3 days
- LocationCranfield Campus
Course structureThe course will be delivered in the form of a three-day residential workshop including lectures and practical sessions. Accompanying lecture notes, will be supplied and support the course throughout.
What you will learn
On completion of the three-day course delegates should be able to:
- Define the requirements and describe the guidance notes for Post Market Surveillance (PMS) sufficiently well to critically design a PMS system appropriate to defined products
- Describe the requirements and guidance notes for vigilance sufficient to write and operate a vigilance procedure which would meet regulatory requirements
- Describe the principles and practice of risk management as set out in ISO 14971 to a level where they can apply it to a complex medical device within the range of the student’s technical competence.
Topics covered by the course include:
- European Regulatory requirements for PMS, including recalls and vigilance
- Responsibility for PMS: Competent Authorities, Notified Bodies and manufacturers
- Other Regulatory requirements – eg. US Medical Device Reports (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 In Vitro Diagnostics (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 eg. MAUDE and EUDAMED
- Global Harmonization Task Force (GHTF) Study Group II.
Who should attendRegulatory affairs professionals
PartnershipsThe course has been developed in partnership with (The Organisation for Professionals in Regulatory Affairs).
SpeakersLectures will be delivered by a number of speakers from industry.
Accommodation options and prices
This course is non-residential. If you would like to book accommodation on campus, please contact Mitchell Hall or Cranfield Management Development Centre directly. Further information about our on campus accommodation can be found here. Alternatively you may wish to make your own arrangements at a nearby hotel.
Location and travel
Cranfield University is situated in Bedfordshire close to the border with Buckinghamshire. The University is located almost midway between the towns of Bedford and Milton Keynes and is conveniently situated between junctions 13 and 14 of the M1.
London Luton, Stansted and Heathrow airports are 30, 90 and 90 minutes respectively by car, offering superb connections to and from just about anywhere in the world.
Read our Professional development (CPD) booking conditions.