Principles & Practices.

“Medical Device Validation”.

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

Medical Device Validation, Regulation, Classification, …



  • How to ensure compliant and efficient Validation of Medical Devices during Development, Manufacturing and Use.
  • The key principles, regulations, standards and current practices.
  • 800+ pages explaining Medical Device Validation.
  • Access online, when and where suits, via your desktop, laptop, tablet, mobile.
 

Contents:

 

FDA Medical Device Regulation.
– FDA Medical Device Classification.
– European Medical Device Regulation (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 Signatures, Electronic Records requirements.
– 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, requirements & expectations of the standard.
– ISO 14971: Objectives of the standard and key areas of focus.
– Medical Device Reporting (FDA requirements).
– The Device Master Record (MDR).
– The Device History Record (DHR).
 

“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).
 

January SALE. 50% OFF.

January SALE. 50% OFF.


Price $59 – SALE Ending this Friday 21st January 2022.

(Recommended Price $119. Price Reduced to $59 – 50% OFF).
 

 

 

Sample Pages.

Medical Device Reporting

Medical Device Reporting



Validation Analysis

Validation Gap Analysis



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



Process Re Validation

Process Re Validation



 

Medical Device Software

Medical Device Software



 

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



 

Price $59 – SALE Ending this Friday 21st January 2022.

(Recommended Price $119. Price Reduced to $59 – 50% OFF).