Quality and Regulatory affairs for Medical Devices industry (priority for BIOMED and M2 NBS students) - 5PMCSMEB

Goal(s)

• Understand what a Quality Management System is and the main quality tools
• Understand the normative and regulatory environment of the industry
• Understand the regulatory requirements for the marketing of a medical device

Content(s)

Quality Management System

• Overview of some industry types and their QMS standards
• Main concepts :
  Exercise: Process risk analysis
• Some quality management tools
  Exercise: Root cause Investigation and CPA

Case study: internal quality audit

The regulatory and normative environment for Medical Device Industry

• What is a Medical Device?
• Medical Devices History
• Procedures for placement on the market
• Economic operators
• Clinical evaluation and clinical investigations
• Applicable regulations and standards
  Exercise: Determination of General safety and performance requirements
• Design file, technical file
• Post market and vigilance requirements
  Exercise: Vigilance example analysis
• Country requirements for market authorizations and Registration (GUDID/Eudamed…)
  Quality and regulatory affairs functions in the industry

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