“Medical Device Validation”.

FDA Validation Requirements | EU Medical Device Regulations | Device Classification | Quality System Requirements, … etc. … etc. …

 

Information & Training Documents – For You & your work Colleagues.

Medical Device Validation, Regulation, Classification, …



  • Medical Device Validation, Regulation, Classification, Risk Identification, … 
  • Enhance your personal understanding.
  • Use to support the training of your work peers.
  • Access online, when and where suits, via your desktop, laptop, tablet, mobile. 
 

“Medical Device Validation” …

Details …
 

FDA Medical Device Regulation.
– FDA Medical Device Classification.
– European Medical Device Regulation and Classification (per MDD’s).
– European Medical Device Regulation (per MDR’s).   
– Current Good Manufacturing Practices. General requirements of the 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. 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).
 

“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).
 

 

Over 800 pages of information ! To Order “Medical Device Validation”:

Available for $59.

Available now for $59.


50% OFF SALE – Reduced price available from Monday 11th to Friday 15th October 2021. (Standard price $119).

Price $59.

 




 

Sample pages from “Medical Device Validation”:

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


 
TO Order Medical Device Validation.