Medical Device Validation, Regulation, Compliance, Risk.

Information & Training presentation.


 
  • Develop your personal understanding of Medical Device Validation, Regulation, etc..
  • 880 pages of information provided in an easy to understand, visual format.
  • Use as a support if providing your own training.
  • Step through at your own pace, in your own time, from the convenience of your desktop, laptop, tablet, mobile.
 

Recommended price $109. Available for $59.

Ends 13th December.

 

Contents:

 

Introduction to Medical Device Validation  
FDA – Medical Device Regulation
FDA – Medical Device Classification
EU – Medical Device Regulation and Classification (MDD’s)
NEW European Medical Device Regulations (MDR’s) – Additional requirements versus the MDD’s. 
Current Good Manufacturing Practices – QSR’s 
Quality System requirements to maintain compliant Validations 
Medical Device Process Validation 
Medical Device Software Validation 
Medical Device Design Validation
Electronic Signature, Electronic Records 
Life Cycle Approach to Validation 
Revalidation 
Validation Master Plan    
Validation and Risk Management 
Validation Protocol Reporting 
Validation Gap Analysis
Packaging in the Healthcare Industry 
Validation Summary 
ISO 13485: Review of requirements
ISO 13485: 2016 Emphasis change from the 2003 revision 
ISO 14971: Review of requirements
Device Master Record (FDA)
Device History Record (FDA)
 

NEW … includes revised requirements due to the new EU Medical Device Regulations (MDR’s 2017 745) … e.g. the “unique device identifier”, the “person responsible for regulatory compliance”, the “Eudamed databank”, device classification “Rule 11” on device Software, revised “conformity assessment” procedures, …
 

 

Sample pages:

Validation Master Plan



 

Process Re-Validation



 

MDR Conformity Assessment



Device Design Control Process



Electronic Records. Electronic Signatures.



European Medical Device Regulations (MDR’s)



 

Price $59 ($119)

 

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