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.

8 03, 2021

Computer Systems Assurance: Making the Transition from Computer Systems Validation

By |2021-03-08T09:00:15+00:00March 8th, 2021|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

For decades, pharmaceutical and medical device companies have operated under the [...]

15 02, 2021

AssurX Webinar – EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution

By |2021-02-15T09:20:39+00:00February 15th, 2021|AssurX News + Success Stories, EU MDR, Medical Device Industry, Uncategorized|

Join us for a one-hour webinar focused on efficient management of postmarket cha [...]

3 02, 2021

Foster Delivery Science Implements AssurX Quality Management and Regulatory Compliance Software

By |2024-06-03T13:23:40+00:00February 3rd, 2021|AssurX News + Success Stories, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Quality Management|

AssurX Platform Automates Document Management and Training Management; More Proc [...]

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 [...]

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