Medical Device Validation. 

Information | Understanding | Best Practice. 

“Easy to follow explanation of validation processes” (J. Matthews. Quality Engineer, Harvard Bioscience Inc.). 
“Has really helped me understand the various aspects associated with validation”, (A. Jackson. Merit Medical Systems). 
“Best explanation I seen yet !”. (M. Williams. Paul Hartmann AG).

Medical Device Validation, Regulation, Classification, …



  • Medical Device Validation, Regulation, Classification, Device Risk. … 
  • 880 pages of visual information.
  • Use to enhance your personal understanding, for personal professional development, as a support in the training of your work peers.
  • Access online, when and where suits, on your personal devices, via a monitor, etc..
  • Price $59.
  • Standard price $119. (50% Off). Ends Friday 14th May.
 

Develop your understanding:
 

FDA Medical Device Regulation.
– FDA Medical Device Classification.
– European Medical Device Regulation and Classification (per MDD’s).
– European Medical Device Regulation per the MDR’s. MDR Classification. MDR General Safety requirements. Additional requirements versus the MDD’s.  
– Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
– Quality System requirements to maintain compliant Validations.
– Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ. 
– Medical Device Software Validation.
– Medical Device Design Validation.
– Electronic Signature, Electronic Records.
– Life Cycle Approach to Validation.
– Revalidation. Identifying the need for re-Validation.
– The Validation Master Plan. 
– Equipment. Component. Material & Facility Validation.
– Validation and Risk Management. 
– Validation Protocol Reporting. 
– Validation Gap Analysis.
– The Validation Summary. 
– ISO 13485 Focus and expectations of the standard.
– ISO 13485: 2016 New requirements.  
– ISO 14971: Objectives of the standard and key areas of focus.
– Medical Device Reporting (FDA).
– The Device Master Record (FDA).
– The Device History Record (FDA).
 

 

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Sample pages:
Validation Analysis

Validation Gap Analysis



The “Unique Device Identifier” per EU MDR’s.



Good Manufacturing Practices

Good Manufacturing Practices



 

Design Process Control



 

MDR 2017 745

MDR 2017 745



Maintaining Validation Status

Maintaining Validation Status



Medical Device equivalence determination.



FDA Medical Device Regulations

Applicability of FDA Medical Device Regulations


 
Medical Device Validation.