Medical Technology Vigilance, Post-Market Surveillance and Risk Management

Description

• Type

  Short course

Description

Course structure The 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.

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Subjects

• Surveillance
• Risk
• Risk Management
• Market
• Technology
• Medical
• Medical training
• IT risk

Course programme

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.

Core content 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.

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