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 04, 2017

Successful QMS Implementation Requires Clearly Defined Processes

By |2024-07-01T22:28:02+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 [...]

10 04, 2017

China Addresses Life Sciences Regulatory Compliance Concerns

By |2017-04-10T13:44:24+00:00April 10th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

China has often faced criticism for lax regulation of drug and medical device ma [...]

3 04, 2017

FDA Warning Letters Emphasize Document Control System Compliance

By |2025-04-03T01:32:10+00:00April 3rd, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]

28 03, 2017

FDA States Clear cGMP Expectations for Combination Products

By |2017-03-28T08:51:56+00:00March 28th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

The Food and Drug Administration (FDA) recently released a final guidance on Cur [...]

20 03, 2017

Avoid QMS Automation Failures with the Right Implementation Team

By |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 [...]

6 03, 2017

Increased QMS Compliance Inspections For International Life Science Manufacturers

By |2024-03-26T20:22:07+00:00March 6th, 2017|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

International QMS compliance inspections of pharmaceutical and medical device ma [...]

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