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.

11 11, 2025

Improving the Supplier Corrective Action Request Process with the QMS

By |2025-11-11T13:32:19+00:00November 11th, 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 I first started developing supplier quality management programs in pharma m [...]

4 11, 2025

AssurX Promotes Stephanie Ojeda to Vice President, Product Management, Life Sciences and Manufacturing

By |2025-11-04T18:49:46+00:00November 4th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Risk Management|

Reno, NV – November 4, 2025 – AssurX, a leading provider of quality management [...]

5 08, 2025

FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations

By |2025-08-05T13:51:41+00:00August 5th, 2025|Document Management, eMDR, EU IVDR, EU MDR, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The U.S. Food and Drug Administration (FDA) released an updated guidance docume [...]

28 07, 2025

5 Essential Elements Shared by Leading Supplier Quality Management Systems

By |2025-07-28T16:33:25+00:00July 28th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

Global-scale events have tested the bounds of a supply chain system. The coronav [...]

23 07, 2025

Why Quality Audits Are Critical for Compliance in FDA and ISO Environments

By |2025-07-23T14:48:04+00:00July 23rd, 2025|Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Quality audits are a cornerstone of compliance in FDA and ISO-regulated environ [...]

9 07, 2025

QMS Validation: How CSA Reduces Documentation Without Increasing Risk

By |2025-07-08T20:34:27+00:00July 9th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Documentation has long been at the heart of quality management system (QMS) val [...]

26 06, 2025

Supplier Scorecards vs. Spreadsheets: Risks of Manual Tracking

By |2025-06-26T14:08:20+00:00June 26th, 2025|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

Spreadsheets are usually the first tool used to manage suppliers, and the first [...]

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