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.

3 02, 2021

Foster Delivery Science Implements AssurX Quality Management and Regulatory Compliance Software
Foster Delivery Science Implements AssurX Quality Management and Regulatory Compliance Software

Foster Delivery Science Implements AssurX Quality Management and Regulatory Compliance Software

By AssurX Blog|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 [...]

21 01, 2021

EU MDR Countdown: What’s Next for Medical Device Compliance
EU MDR Countdown: What’s Next for Medical Device Compliance

EU MDR Countdown: What’s Next for Medical Device Compliance

By AssurX Blog|2021-01-21T08:00:47+00:00January 21st, 2021|eMDR, EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

In four months, the new EU Medical Device Regulation (MDR) goes into effect, whi [...]

19 01, 2021

Addressing the EU MDR and IVDR Certification Bottleneck
Addressing the EU MDR and IVDR Certification Bottleneck

Addressing the EU MDR and IVDR Certification Bottleneck

By AssurX Blog|2021-01-19T07:00:36+00:00January 19th, 2021|EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

With the May 26, 2021 implementation deadline looming for the new EU Medical Dev [...]

11 01, 2021

EU MDR Compliance Check-in: Challenges and Action Items
EU MDR Compliance Check-in: Challenges and Action Items

EU MDR Compliance Check-in: Challenges and Action Items

By AssurX Blog|2021-01-11T07:36:20+00:00January 11th, 2021|EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The new EU Medical Device Regulation (MDR) goes into effect in less than six mon [...]

3 12, 2020

How to Meet New EU MDR Requirements for Vigilance and Reporting
How to Meet New EU MDR Requirements for Vigilance and Reporting

How to Meet New EU MDR Requirements for Vigilance and Reporting

By AssurX Blog|2024-01-13T02:07:39+00:00December 3rd, 2020|Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

After a one-year delay due to concerns over a shortage of notified bodies, the n [...]

3 04, 2020

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

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

By AssurX Blog|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
The Six C’s of a Modern Complaint Management System 2020

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

By AssurX Blog|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
Human Error is a Precipitator for Root Cause Analysis, Not Blame

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

By AssurX Blog|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
Assurx2020 Further Modernizes Efficiencies In Automating Quality Management

Assurx2020 Further Modernizes Efficiencies In Automating Quality Management

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

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

By AssurX Blog|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 [...]