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A Step-by-step guide to Medical Device Quality System Management

Dot Compliance

Government regulators have been doing their best to ensure that patients receive the safest and most efficient device possible. The two most relevant quality regulations for medical device manufacturers are the FDA 21 CFR Part 820 and the ISO 13485:2016. The FDA 21 CFR Part 820 is similar to the ISO 13485:2016.

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SQA News | Summer 2021

SQA

Thanks again and please contact me with any thoughts, ideas or areas of concern mmckay@sqaservices.com. SoCal Parenteral Drug Association (PDA) Chapter 10th Annual Industry Summit (Vendor Night) , August 24 at The Grande event center in Long Beach, CA [link]. Yours in Quality , Mike McKay. President/CEO. Out & About with Team SQA.

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