MSc MTRA: Module 5 - Medical Devices Vigilance, Post-Market Surveillance and Risk Management

Medical Device Vigilance, Post-Market Surveillance (PMS) and Risk Management

Aim

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

Lectures

Topics covered include:

• European Regulatory requirements for PMS, including recalls and vigilance
• Responsibility for Post-Market Surveillance (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

Learning outcomes

Upon completion of the course candidates will be able to:

• Define the requirements and describe the guidance notes for 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 the ISO 14971 to a level where they can be applied to a complex medical device within the range of the candidate’s technical competence.

Teaching and learning methods

Lecturers are drawn from a variety of backgrounds and all are recognised experts currently working in the field of Medical Device Technology related
regulatory affairs. There will be a mix of formal lectures, tutorials, discussions and case studies.

Medical Technology Regulatory Affairs MSc

In collaboration with TOPRA, the Cranfield MSc provides for the first time a recognised way for professionals working within healthcare regulatory affairs or related areas to formalise their skills in the field of medical technology. Available on a part-time basis only, the MSc is designed to be flexible to fit around your current job and responsibilities. The course is also available at Diploma and Certificate levels. For even greater flexibility, and for professionals with a specific interest, individual modules can be attended as standalone three-day short courses.

For more information about our MSc please contact our Enquiries Office Tel: +44 (0) 1234 758008 Email: enquiries.health@cranfield.ac.uk

In order to access comprehensive information about this particular MSc, please click on the following link - Enquiry Form