Medical Device Validation.

Information & training presentation. 

  • Validation requirements from product design, through manufacturing and end use.
  • Step through at your own pace from the convenience of your desktop, laptop, tablet, mobile.
  • View as often as you wish, from a location that suits you, when suits you.
  • Inform yourself on the essential aspects of Medical Device Validation & related regulations.
  • Understand US FDA and EU “CE” expectations related to Medical Devices.
  • The information provided in a visual, easy to understand format.
  • Use as a training tool for peers, work colleagues.
  • 770 pages of information, available today for $25.

Topics covered:
  • Introduction to Medical Device Regulatory Requirements and International Standards.
  • How to implement Medical Device Process Validation. 
  • USFDA approach to Medical Device Regulation.
  • USFDA Medical Device Classification.
  • Medical Device Regulation in Europe.
  • ISO13485: 2016 revision changes – Medical Devices – Quality Management Systems.
  • Medical Device Validation of product and process Software.
  • Implementation of a compliant Medical Device Design and Development process.
  • The Life Cycle Approach to Validation.
  • Implementing an on-going reValidation process.
  • Creating a comprehensive Validation Master Plan (VMP).
  • How to perform a Validation Gap Analysis.
  • Current Good Manufacturing Practices (cGMP’s).
  • The key validation related components of an effective Quality Management System.… Documentation. 
  • How to identify the need for Validation based on identifying and quantifying Risk.
  • Packaging in the Medical Device industry.
  • Planning, documentation and reporting Validation Protocols.

Internet access required to access.
Standard price of $49 for 12 months access and use. Available today at $25.
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