Medical Device:

Validation, Regulation, Classification, … 

Information and training presentation.

… manufacturing validation, validation in design and development, validation life cycle, validation quality assurance, medical device software, good manufacturing practice, risk driven validation, device classification, FDA CFR & EU Device Directive requirements, …

 
  • Medical Device requirements from product development, through manufacturing and end use.
  • Step through at your own pace from the convenience of your desktop, laptop, tablet, mobile.
  • Use to develop your personal knowledge.
  • Use as a support if providing training.
  • 780 pages of information, provided in an easy to understand, visual format.
  • Price $79. Price $59.
  • Any questions? Please contact us.
 

Medical Device Validation Full Details

Medical Device Validation.


Contents:

 
  • Introduction to regulatory requirements and international standards.
  • How to implement Medical Device Process Validation.
  • Software Validation for Medical Device products and processes.
  • Implementation of a compliant Medical Device design and development process.
  • The Life Cycle Approach to Validation:
    • Implementing a Life Cycle Approach. Installation Qualification (I.Q.). Operation Qualification (O.Q.). Pre-Validation Study (PVS). Performance Qualification (P.Q.).
  • Implementing an on-going revalidation process.
  • How to perform a Validation Gap Analysis.
  • How to classify a Medical Device.
  • Current Good Manufacturing Practices (cGMP’s):
    • Principles of current Good Manufacturing Practice (cGMP). The concept of a device being “fit for intended purpose”. The FDA Quality System Regulations (QSR’s) explained.
  • How to identify the need for Validation based on identifying and quantifying Risk.
  • Planning, documentation and reporting validation protocols.
 

 

Sample Pages:

Revalidation and Change Management.



 

Medical Device Validation

Process Re-Validation



 

Medical Device equivalence determination.



 

FDA label requirements.



 
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