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.

3 04, 2020

Don’t take your foot off the gas on EU MDR implementation

By |2020-04-03T15:31:23+00:00April 3rd, 2020|eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The coronavirus has had a massive impact on the medical device industry.  As a c [...]

10 03, 2020

The Six C’s of a Modern Complaint Management System 2020

By |2020-03-10T07:15:08+00:00March 10th, 2020|Complaint Management, Document Management, eMDR, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Regulators such as FDA, European Commission (EC), ISO 13485  require a product c [...]

21 02, 2020

Human Error is a Precipitator for Root Cause Analysis, Not Blame

By |2024-06-03T13:33:05+00:00February 21st, 2020|Document Management, eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management, SaaS & Cloud Computing|

Have you ever been part of a process that had a failure or two? Perhaps you’ve b [...]

10 02, 2020

Assurx2020 Further Modernizes Efficiencies In Automating Quality Management

By |2020-02-10T16:34:51+00:00February 10th, 2020|AssurX News + Success Stories, Document Management, eMDR, Energy & Utilities Industry, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, NERC Compliance, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management, SaaS & Cloud Computing|

Morgan Hill, CA., January 22, 2020, – AssurX, Inc., a leader in enterprise quali [...]

5 02, 2020

AssurX Releases Manufacturing Incident Report Solution for EU MDR Report Automation for Medical Device Manufacturers

By |2020-02-05T08:04:37+00:00February 5th, 2020|AssurX News + Success Stories, eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Regulatory Compliance Management|

Morgan Hill, CA., February 5, 2020 – AssurX, Inc., a leader in enterprise qualit [...]

23 01, 2020

Configuration vs. Customization for Enterprise QMS Software

By |2020-01-23T07:00:24+00:00January 23rd, 2020|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

Experience shows that out-of-the-box configured software only works for business [...]

11 12, 2019

Looking Ahead: 2020 Life Sciences Technology Trends

By |2025-04-04T02:14:25+00:00December 11th, 2019|Document Management, eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management, Uncategorized|

The Life Sciences industry has always been fast-paced and competitive. Changes [...]

4 09, 2019

Cybersecurity for Medical Devices – Who’s Accountable?

By |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 [...]

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