Medical Device Validation, Regulation, Compliance.780 page information & training presentation, which details how to implement effective manufacturing validation, validation through design and development, FDA & EU regulatory requirements, validation life cycle, validation quality assurance, medical device software validation, good manufacturing practice, risk driven validation, device classification, …
- Validation requirements from product design, through manufacturing and end use.
- Medical Device Regulatory expectations and standards.
- Step through at your own pace from the convenience of your desktop, laptop, tablet, mobile.
- Use to inform yourself on the essential aspects of Medical Device compliance, regulation, validation.
- Use in the training of your work peers.
- Information provided in an easy to understand, visual format.
- Price $75 for 1 year’s unlimited use.
Contents of the Medical Devices information and training presentation.
How to implement Medical Device Process Validation.
US FDA approach to Medical Device Regulation.
US FDA Medical Device Classification.
Medical Device Regulation in Europe.
ISO 13485 Medical Devices – Quality Management Systems.
Software Validation for Medical Device products and processes.
Implementation of a compliant Medical Device design and development process.
The Life Cycle Approach to Validation.
Implementing an on-going revalidation process.
Creating a comprehensive Validation Master Plan (VMP).
How to perform a Validation Gap Analysis.
Current Good Manufacturing Practices (cGMP’s).
The key validation related components of an effective Quality Management System.
How to identify the need for Validation based on identifying and quantifying Risk.
Planning, documentation and reporting validation protocols.
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