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.
DHR
Managing Risks
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.
The Significance of Design Controls
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.
Understanding DHF’s, DMR’s, and DHR’s
If you are a part of the medical device industry, you are probably familiar with just how many “must know” acronyms...
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