Medical Device Validation, Regulation, Compliance, Risk.
Information & 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.
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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
Validation Master Plan
Validation and Risk Management
Validation Protocol Reporting
Validation Gap Analysis
Packaging in the Healthcare Industry
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, …
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