Medical Device Validation. 

Current 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, 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..
  • Available Now for $59.
 

 

Access details (PIN Code and URL Address) issued within 24 hours.
 

Develop your understanding:

 

– Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ. 
– Life Cycle Approach to Validation.
– Revalidation. Identifying the need for re-Validation.
– The Validation Master Plan. 
FDA Medical Device Regulation & Device Classification.
– Medical Device Software Validation.
– Medical Device Design Validation.
European Medical Device Regulations.  
– Current Good Manufacturing Practices. QSR’s.
– Quality System requirements to maintain compliant Validations.
– Electronic Signature, Electronic Records.
– Quality System requirements to maintain compliant Validations.
– 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 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).
 

 
Order Now: Medical Device Validation.
 

 

Extracts:

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


 
Order Now: Medical Device Validation.