Electronic Medical Device Reporting Solutions by AssurX

AssurX streamlines electronic medical device reporting (eMDR) for FDA compliance. Our platform automates data formatting, validation, and submission, ensuring timely and accurate reporting. Enhance your regulatory processes with real-time status updates and seamless integration for global compliance.

All Roads Lead to ISO 13485: The Global Context
All Roads Lead to ISO 13485: The Global Context

All Roads Lead to ISO 13485: The Global Context

AssurX Blog2025-10-03T04:48:40+00:00May 5th, 2021|

As regulations and standards evolve, one trend is continually sharpening in foc [...]

How to Meet New EU MDR Requirements for Vigilance and Reporting
How to Meet New EU MDR Requirements for Vigilance and Reporting

How to Meet New EU MDR Requirements for Vigilance and Reporting

AssurX Blog2024-01-13T02:07:39+00:00December 3rd, 2020|

After a one-year delay due to concerns over a shortage of notified bodies, the n [...]

Medical Device Manufacturers Warned For CAPA Non-Compliance
Medical Device Manufacturers Warned For CAPA Non-Compliance

Medical Device Manufacturers Warned For CAPA Non-Compliance

AssurX Blog2023-02-27T19:48:41+00:00June 13th, 2017|

Three recent warning letters from the Center for Device and Radiological Health [...]

FDA Warning Letters Emphasize Document Control System Compliance
FDA Warning Letters Emphasize Document Control System Compliance

FDA Warning Letters Emphasize Document Control System Compliance

AssurX Blog2025-04-03T01:32:10+00:00April 3rd, 2017|

First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]

Risk Management + Adverse Event Reporting: FDA Guidance
Risk Management + Adverse Event Reporting: FDA Guidance

Risk Management + Adverse Event Reporting: FDA Guidance

AssurX Blog2016-12-16T10:21:33+00:00December 16th, 2016|

Risk management and adverse event reporting protocols for medical device manufac [...]

FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR

Tamar June2015-04-28T07:14:17+00:00April 28th, 2015|

FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline [...]

FDA’s Local Offices Flex Regulatory Muscle

AssurX Blog2014-11-24T11:01:23+00:00November 24th, 2014|

In our latest round-up, it was the District Offices turn to chime in on medical [...]

Are You Ready for 21st Century eMDR Submissions?
Are You Ready for 21st Century eMDR Submissions?

Are You Ready for 21st Century eMDR Submissions?

AssurX Blog2014-11-21T10:35:19+00:00November 21st, 2014|

Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been pr [...]

FDA Guidance Advises Device Makers to Think About Home-Use

AssurX Blog2025-10-02T22:12:37+00:00August 13th, 2014|

Medical device manufacturers would be well-advised to address any potential risk [...]