Electronic Medical Device Reporting | eMDR | AssurX

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Opinion: 3 Reasons to Consider SaaS for Quality Management Software

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AssurX BlogQuality, compliance and risk management straight talk for regulated industries.

The Importance of Documenting Enterprise QMS Process Requirements

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Blog Home TAG: Electronic Medical Device Reporting

How to Meet New EU MDR Requirements for Vigilance and Reporting

In Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management

Posted December 3, 2020

How to Meet New EU MDR Requirements for Vigilance and Reporting

After a one-year delay due to concerns over a shortage of notified bodies, the new EU Medical Device Regulation (MDR) is set to take effect as of May 26, 2021. The regulations are a departure [...]

Medical Device Manufacturers Warned For CAPA Non-Compliance

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

Posted June 13, 2017

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

Posted April 3, 2017

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 [...]

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