Electronic Medical Device Reporting | eMDR | AssurX

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Blog Home TAG: Electronic Medical Device Reporting

Medical Device Manufacturers Warned For CAPA Non-Compliance

In Archives, Medical Device Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance Management

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Medical Device Manufacturers Warned For CAPA Non-Compliance

Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical device inspection investigative focus. CAPA non-compliance is a top [...]

FDA Warning Letters Emphasize Document Control System Compliance

By Michael Causey

In Archives, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management

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FDA Warning Letters Emphasize Document Control System Compliance

First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples. Both [...]

Risk Management + Adverse Event Reporting: FDA Guidance

In Archives, eMDR, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management

Posted

Risk Management + Adverse Event Reporting: FDA Guidance

Risk management and adverse event reporting protocols for medical device manufacturers have been addressed by a new FDA guidance. Producing and controlling electronic records will be critical to [...]

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