Medical Device

Validation, Regulation, Compliance, Risk Mitigation, … requirements & current best practices. Information & Training Presentation.


Medical Device Validation

Validation. Regulation. Classification. Risk Mitigation. … Etc.



  • Medical Device Validation, Regulation, etc., requirements & best practices.
  • Develop your personal understanding.
  • Use as a support, if providing training to others.
  • Over 800 pages of information provided in a visual,  easy to comprehend format.
  • Step through at your own pace, in your own time, from the convenience of your desktop, laptop, tablet, mobile.
  • Price: $75*.
 

* Recommended price of $149. Available now for $75
 

50% OFF SALE – ENDS FRIDAY 10th JULY


Contents:

 

Introduction to Medical Device Validation  
FDA – Medical Device Regulation
FDA – Medical Device Classification
EU – Medical Device Regulation and Classification (per 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
Validation Summary 
ISO 13485: 2003 Review of requirements
ISO 13485: 2016 Changes 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, …
 

Note: The EU MDR’s “Date of Application” has currently been extended for one year, from 26th May 2020 to 26th May 2021 due to the impact of Covid 19.
 

Sample Pages & Ordering:

Validation Master Plan

Validation Planning



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



Good Manufacturing Practices

Good Manufacturing Practices



 

Medical Device Validation



 

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


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