Information and Training presentation. 

Medical Device Validation, Regulation, Classification, …


Medical Device Validation Training requirements and best practices.



  • Medical Device Product & Process Validation, FDA & EU Regulations, Device Classification, Risk Identification, Documentation, Etc..
  • 800+ pages of information provided in a visual, easy to understand format.
  • Use as a support in the training of your work peers.
  • Access online when and where suits.
  • 50% OFF.   Monday 30th to Friday 4th December. Available for $59. Recommended price $119.
 

Medical Device Validation, Regulation, Classification, … 

50% OFF. Monday 30th to Friday 4th December.

50% OFF. Monday 30th to Friday 4th December.



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 Focus and expectations of the standard..
– ISO 13485: 2016 New requirements versus the previous revision.  
– 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).
 

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 Pages & To Order:

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 the Medical Device Validation Training presentation …