Medical Device Validation.

800 pages Information | Training | Learning. 


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  • Develop your understanding of requirements and best practices in Medical Devices Validation.
  • Understand relevant Regulations, Device Classification, Risk Assessment & Mitigation, Documenting Validations, Etc..
  • Inform yourself, at your pace, from the convenience of your desktop, laptop, tablet, mobile.
  • Use as a support, if training or educating your peers.
  • Price $149.
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Contents:

 

– Introduction to Medical Device Validation. 
– FDA Medical Device Regulation. Outline of the US FDA regulatory requirements.
– FDA Medical Device Classification. The US FDA approach to Medical Device classification.
– EU Medical Device Regulation and Classification (per MDD’s).
NEW European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements. Additional requirements versus the MDD’s.  
– Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
– Quality System requirements to maintain compliant Validations.
– Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ. 
– 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 Review of requirements.
– ISO 13485: 2016 New requirements versus the 2003 revision.  
– ISO 14971: Review of requirements.
– Medical Device Reporting (FDA).
– The Device Master Record (FDA).
– The 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 Views & Ordering:

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



 

 

 
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