Medical Device Validation.Information & training presentation.
- Validation requirements from product design, through manufacturing and end use.
- Step through at your own pace from the convenience of your desktop, laptop, tablet, mobile.
- View as often as you wish, from a location that suits you, when suits you.
- Inform yourself on the essential aspects of Medical Device Validation & related regulations.
- Understand US FDA and EU “CE” expectations related to Medical Devices.
- The information provided in a visual, easy to understand format.
- Use as a training tool for peers, work colleagues.
- 770 pages of information, available today for $25.
- Introduction to Medical Device Regulatory Requirements and International Standards.
- How to implement Medical Device Process Validation.
- USFDA approach to Medical Device Regulation.
- USFDA Medical Device Classification.
- Medical Device Regulation in Europe.
- ISO13485: 2016 revision changes – Medical Devices – Quality Management Systems.
- Medical Device Validation of product and process Software.
- 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.… Documentation.
- How to identify the need for Validation based on identifying and quantifying Risk.
- Packaging in the Medical Device industry.
- Planning, documentation and reporting Validation Protocols.
Internet access required to access.
Standard price of $49 for 12 months access and use. Available today at $25.
Any questions about ordering, contents, etc, ?
Just ask us on Twitter or LinkedIn or “Contact Us”