Medical Device Industry

The “Medical Device Industry” category at AssurX focuses on the unique needs and challenges of this highly regulated sector. This section provides insights into quality management, regulatory compliance, and process optimization specifically for medical device manufacturers. Topics include navigating complex regulations, ensuring product safety, and improving operational efficiency. With AssurX’s expertise, medical device professionals can maintain compliance, enhance quality, and drive innovation, ensuring products meet stringent industry standards.

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 [...]

3 12, 2019

Elements of a Modern and Efficient Change Management System

By |2025-03-18T08:52:55+00:00December 3rd, 2019|Energy & Utilities Industry, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

An efficiently designed change management system clearly defines how strategies, [...]

26 09, 2019

FDA’s Fast Track Model for Software as a Medical Device (SaMD) Requires a Culture of Quality

By |2024-01-13T02:42:40+00:00September 26th, 2019|FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Uncategorized|

Want to be part of FDA’s SaMD precertification program? Get your quality managem [...]

13 09, 2019

AssurX Demonstrating Regulatory & Quality Management Solutions at 2019 RAPS Conference

By |2024-12-31T23:15:05+00:00September 13th, 2019|AssurX News + Success Stories, Document Management, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Next week, AssurX will be exhibiting at the annual Regulatory Affairs Profession [...]

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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