Patient Focus - It's time to listen
To improve the Medical Device Reporting (MDR) submissions process, Nostrapharmus recommends that companies need to put the patient before the product.
The medical device industry is facing increasing pressure from US congress and greater FDA scrutiny owing to several product recalls that have affected patient safety. During a GMP inspection, an FDA investigator usually starts with a device company's MDR files, partly because violations for missed deadlines and failure to report are often easy to spot. Hence, there is a pressing need within the industry to improve the MDR submissions process. Nostrapharmus suggests immediately 'the best place to start is quite simple - listen and focus on the patient.'
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Patient Focus - It's time to listen
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