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How Medical Device Companies Can Maintain FDA 21 CFR Part 820 Compliance

For medical device manufacturers, meeting compliance standards is an essential piece of the quality process. One of the most important of these necessary regulations is FDA 21 CFR Part 820, which ensures that medical devices are safe and effective....

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Tags: FDA Compliant Document Control Software, medical device regulations, FDA 21 CFR Part 820

5 Ways to Prepare For The New UK Medical Device Regulations

Over the next couple of months, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) is expected to roll out new guidance that will alter the way medical device products are regulated. Preparing for this change may be...

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Tags: regulatory, medical device, medical device regulations, UK, UK regulations

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