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Computer System Validation News
How Are You Managing Your Postmarket Cybersecurity Vulnerabilities For Medical Devices?
January 05, 2017At the end of 2016, the FDA published Guidance for Industry and FDA Staff, Postmarket Management of Cybersecurity in Med...
Is Your Medical Device Compliant With The Second Draft Of The WHO Global Model Regulatory Framework?
November 01, 2016In mid-2016, the World Health Organization (WHO) published the 2nd draft of Global Model Regulatory Framework for Medica...
Are You Following the FDA Medical Device Cybersecurity Guidance?
February 18, 2016In January the FDA published draft cybersecurity recommendations for marketed medical devices to protect patient safety....
Are you ready for the FDA guidance on the design of Interoperable Medical Devices?
February 11, 2016If your electronic medical device exchanges data with other devices, you need to read the new draft guidance just publis...
What do you need to know about the new FDA guidance on Manufacturing Site Changes?
November 16, 2015Recently, the FDA drafted this guidance document to help the medical device industry make decisions around manufacturing...