Cranfield University Offers Medical Technology Vigilance Course

Cranfield University in the United Kingdom has announced a new short course titled Medical Technology Vigilance: Postmarket Surveillance (PMS) and Risk Management. The three-day course, which is scheduled for 21 to 23 September 2010, will define the terminology and explain the concepts of vigilance, PMS and risk management, their practical applications and integration into the lifecycle of a medical device.

The course is also Module 5 of the MSc in Medical Technology Regulatory Affairs. As such, attendance would count towards the completion of the MSc if the student were to successfully complete the assessments and enroll onto the qualification.

The short course will address the following topics:

• European regulatory requirements for PMS
• Responsibility for PMS
• Other regulatory requirements
• Guidance documents for PMS
• Key reactive and proactive elements of PMS
• Tailoring PMS systems to specific products
• Principles of ISO 14971
• Requirements of ISO 13485
• Feedback of PMS data into the risk management process
• Exchange of information via databases such as MAUDE and EUDAMED
• GHTF Study Group II

For more information, go to the university’s medical technology page.

Tags: Cranfield, short course, vigilance