.... Understand the essentials of Medical Device Validation.
Medical Device Design, Manufacture, Processing, Release to Customers, Product Use
US, European, Australian Medical Device regulatory requirements.
Validation of Medical Devices
Below are links to a range of documents detailing key regulatory and compliance expectations
for Medical Device Validation, per the US FDA CFR’s, the European Medical Device
Directives and the Australian Therapeutic Goods Administration Guidance requirements
for Medical Devices. Each of these documents in turn links to other related requirements,
such as medical device risk management, Validation Master Plan expectations, statistical
analysis methodologies and analytical techniques. Note: The links below will open
in a new window in order to facilitate the retention of this master link page.
If you have questions, related to the Validation of Medical Devices please .....
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Definitions of medical devices as detailed in the United States, Australia, Canada,
European Union, New Zealand, South Africa, the World Health Organization, the International
Medical Device Regulators Forum.....http://www.presentationeze.com/blog/medical-device/