eMDR | AssurX

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.

4 10, 2019

AssurX EU MDR Webinar Follow-Up: 10 FAQs for Tackling EU MDR Data Management
AssurX EU MDR Webinar Follow-Up: 10 FAQs for Tackling EU MDR Data Management

AssurX EU MDR Webinar Follow-Up: 10 FAQs for Tackling EU MDR Data Management

By AssurX Blog|2019-10-04T11:13:38+00:00October 4th, 2019|eMDR, FDA Regulated Industries, Medical Device Industry, Quality Management|

Last month, AssurX hosted a webinar entitled “Who Moved my MDR? Assessing Organi [...]

4 09, 2019

Cybersecurity for Medical Devices – Who’s Accountable?
Cybersecurity for Medical Devices – Who’s Accountable?

Cybersecurity for Medical Devices – Who’s Accountable?

By AssurX Blog|2019-09-04T15:44:11+00:00September 4th, 2019|eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management, SaaS & Cloud Computing|

Cybersecurity for Medical Devices is on the agenda for the U.S. Food and Drug Ad [...]

15 08, 2019

EU MDR Compliance: An Opportunity for Change
EU MDR Compliance: An Opportunity for Change

EU MDR Compliance: An Opportunity for Change

By AssurX Blog|2019-08-15T07:00:44+00:00August 15th, 2019|eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Uncategorized|

EU MDR Compliance: The new European device regulation will bring about impactful [...]

18 06, 2019

FDA to Sunset Alternative Summary Reporting (ASR) Program
FDA to Sunset Alternative Summary Reporting (ASR) Program

FDA to Sunset Alternative Summary Reporting (ASR) Program

By AssurX Blog|2023-03-08T23:16:10+00:00June 18th, 2019|eMDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The FDA has announced an end to the alternative summary reporting (ASR) program [...]

17 04, 2017

Prioritize QMS Process Automation or Risk Failure
Prioritize QMS Process Automation or Risk Failure

Prioritize QMS Process Automation or Risk Failure

By AssurX Blog|2024-07-24T18:19:34+00:00April 17th, 2017|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

A common pitfall in QMS process automation occurs with a poorly planned process [...]

11 04, 2017

Successful QMS Implementation Requires Clearly Defined Processes
Successful QMS Implementation Requires Clearly Defined Processes

Successful QMS Implementation Requires Clearly Defined Processes

By AssurX Blog|2025-05-19T18:56:35+00:00April 11th, 2017|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Industry-leading quality management systems (QMS) are built with clearly defined [...]

20 03, 2017

Avoid QMS Automation Failures with the Right Implementation Team
Avoid QMS Automation Failures with the Right Implementation Team

Avoid QMS Automation Failures with the Right Implementation Team

By AssurX Blog|2024-07-01T22:30:41+00:00March 20th, 2017|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Even after decades of eQMS availability, a staggering number of projects still s [...]

16 12, 2016

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

Risk Management + Adverse Event Reporting: FDA Guidance

By AssurX Blog|2016-12-16T10:21:33+00:00December 16th, 2016|Archives, eMDR, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

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

14 07, 2015

FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures

By AssurX Blog|2023-03-08T22:53:44+00:00July 14th, 2015|Archives, eMDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

It’s been a little while since we checked the FDA’s outgoing mail tray to find o [...]

19 06, 2015

FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting
FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting

FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting

By Tamar June|2025-05-19T19:01:30+00:00June 19th, 2015|Archives, eMDR, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Looks like it's crunch time for medical device manufacturers. Whether they subm [...]