Full Circle Consulting
EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.
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Full Circle Consulting
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Quality System Development
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EU MDR and IVDR
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Full Circle Consulting Resources
Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system. 21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1] The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.
All of life entails some about of risk. The most humans can really do is mitigate the destructive effects of these risks that we take on a daily basis., the same goes with medical devices.
In the 1980s, the Food & Drug Administration (FDA) studied the causes of voluntary recalls of medical devices. Between October 1983 and September 1989, they found that about forty-four percent of these recalls were due to design issues.
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