Medical Device Validation.
800 pages Information | Training | Learning.
- 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.
- 20% OFF. Available now for $119.
– 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.
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