eMDR

The “eMDR” category at AssurX helps organizations manage electronic Medical Device Reporting efficiently. This section offers insights into automating reporting processes, ensuring accurate submissions, and meeting regulatory requirements. It covers topics like understanding eMDR protocols, optimizing data management, and using technology for seamless reporting. AssurX provides expertise to improve reporting accuracy, reduce compliance risks, and enhance operational efficiency in the medical device industry.

17 06, 2025

QMS Software: When to Configure and When to Customize

By |2025-06-17T15:25:23+00:00June 17th, 2025|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

When it comes to managing quality and compliance in today’s regulated industries [...]

1 09, 2022

Why an EQMS is Essential for FDA Remote Regulatory Assessments

By |2024-01-13T01:22:12+00:00September 1st, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The global pandemic brought an unexpected change – FDA remote regulatory assessm [...]

25 08, 2022

EU MDR & IVDR Regulation: Where Does the Guidance Stand?

By |2023-03-09T00:38:13+00:00August 25th, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Companies marketing devices in the European Union are facing a perfect storm of [...]

26 05, 2022

EU Medical Device Regulation Still Presents Challenges and Opportunities

By |2024-12-31T23:16:11+00:00May 26th, 2022|EU IVDR, EU MDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]

15 02, 2021

AssurX Webinar – EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution

By |2021-02-15T09:20:39+00:00February 15th, 2021|AssurX News + Success Stories, EU MDR, Medical Device Industry, Uncategorized|

Join us for a one-hour webinar focused on efficient management of postmarket cha [...]

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