Medical Device Validation, Regulation, Compliance, Risk.

Information & training presentation.

Information and Training presentation



 
  • Develop your personal understanding of Medical Device Validation, Regulation, etc..
  • 880 pages of information provided in an easy to understand, visual format.
  • Use as a support if providing your own training.
  • Step through at your own pace, in your own time, from the convenience of your desktop, laptop, tablet, mobile.
 


50% OFF – Extended to Sunday 20th October 2019. 
Order now for $59 ($119).
 

Contents:

 

Introduction to Medical Device Validation  
FDA – Medical Device Regulation
FDA – Medical Device Classification
EU – Medical Device Regulation and Classification (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
Packaging in the Healthcare Industry 
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, …
 

 

Sample views (6. No):

 

Medical Device Regulations. Unique Device Identifier.

Medical Device Regulations. Unique Device Identifier.



Revalidation and Change Management.



 

Medical Device Validation

Process Re-Validation



 

EU MDR. Medical Device Regulation. Timeline.

EU MDR. Medical Device Regulation. Timeline.



Medical Device Design.

Medical Device Design.



FDA Part 11 Requirements


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