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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.

19 06, 2019

TEDOR Pharma selects AssurX Quality Management Software to Automate and Streamline Processes
TEDOR Pharma selects AssurX Quality Management Software to Automate and Streamline Processes

TEDOR Pharma selects AssurX Quality Management Software to Automate and Streamline Processes

By Tracy Orlick|2023-12-01T00:11:46+00:00June 19th, 2019|AssurX News + Success Stories, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

TEDOR expects to gain operational efficiencies for future growth using the Assur [...]

18 06, 2019

FDA to Sunset Alternative Summary Reporting (ASR) Program
FDA to Sunset Alternative Summary Reporting (ASR) Program

FDA to Sunset Alternative Summary Reporting (ASR) Program

By AssurX Blog|2023-03-08T23:16:10+00:00June 18th, 2019|eMDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The FDA has announced an end to the alternative summary reporting (ASR) program [...]

30 05, 2019

Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest
Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest

Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest

By AssurX Blog|2024-11-20T20:17:20+00:00May 30th, 2019|FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

FDA regulation 21 part 822 lays out the process, the rules, and the products th [...]

20 03, 2019

What to Make of FDA’s Secret Cache of Device Adverse Events
What to Make of FDA’s Secret Cache of Device Adverse Events

What to Make of FDA’s Secret Cache of Device Adverse Events

By AssurX Blog|2025-01-10T20:37:56+00:00March 20th, 2019|FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Last week an investigative report revealed the FDA has millions of “hidden” seri [...]

24 04, 2018

Visit AssurX at the ASQ World Conference on Quality & Improvement (WCQI)
Visit AssurX at the ASQ World Conference on Quality & Improvement (WCQI)

Visit AssurX at the ASQ World Conference on Quality & Improvement (WCQI)

By AssurX Blog|2024-07-01T22:17:54+00:00April 24th, 2018|Energy & Utilities Industry, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

AssurX, a leader in quality management software systems, will exhibit at the 201 [...]

27 03, 2018

Check Your Policy Management System Health
Check Your Policy Management System Health

Check Your Policy Management System Health

By Sal Lucido|2018-03-27T09:18:30+00:00March 27th, 2018|FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Policies and procedures tell your employees, partners, vendors, and customers ho [...]

14 03, 2018

Opinion: 3 Reasons to Consider SaaS for Quality Management Software
Opinion: 3 Reasons to Consider SaaS for Quality Management Software

Opinion: 3 Reasons to Consider SaaS for Quality Management Software

By AssurX Blog|2018-03-14T13:49:08+00:00March 14th, 2018|FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

If you've been thinking about Software as a Service (SaaS) for your QMS and tryi [...]

24 10, 2017

Cybersecurity Preparedness, Equifax, and Ben Franklin
Cybersecurity Preparedness, Equifax, and Ben Franklin

Cybersecurity Preparedness, Equifax, and Ben Franklin

By Kathryn Wagner|2017-10-24T08:42:34+00:00October 24th, 2017|Energy & Utilities Industry, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Regulatory Compliance Management|

Cybersecurity Preparedness: The prudent advice Benjamin Franklin shared with the [...]

13 06, 2017

Medical Device Manufacturers Warned For CAPA Non-Compliance
Medical Device Manufacturers Warned For CAPA Non-Compliance

Medical Device Manufacturers Warned For CAPA Non-Compliance

By AssurX Blog|2023-02-27T19:48:41+00:00June 13th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Three recent warning letters from the Center for Device and Radiological Health [...]

16 05, 2017

How Will Real-World Evidence Impact 2017 FDA Guidances?
How Will Real-World Evidence Impact 2017 FDA Guidances?

How Will Real-World Evidence Impact 2017 FDA Guidances?

By AssurX Blog|2024-07-01T22:24:36+00:00May 16th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The Advanced Medical Technology Association (AdvaMed) wants the Food and Drug A [...]