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 08, 2015

FDA Takes GUDID Offline: Security breach? Or Proactive Measures?

By Tamar June|2015-08-19T07:51:11+00:00August 19th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management, Risk Management|

FDA detected a "security vulnerability" earlier this month that spooked it enoug [...]

11 08, 2015

Cybersecurity – A Real Threat to Medical Devices

By AssurX Blog|2015-08-11T09:52:05+00:00August 11th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Risk Management|

The FDA just issued a Safety Communication on cybersecurity vulnerabilities of t [...]

4 08, 2015

GAO Report Finds Steady Medical Device Profit Climb – Especially the Big Boys

By AssurX Blog|2015-08-04T17:58:23+00:00August 4th, 2015|Archives, Medical Device Industry|

Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals [...]

23 07, 2015

Obama Veto Threat Looms Over Medical Device Tax Battle

By AssurX Blog|2015-07-23T06:34:32+00:00July 23rd, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals [...]

20 07, 2015

FDA’s UDI Initiative Continues to Roll Forward

By AssurX Blog|2015-07-20T07:26:42+00:00July 20th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Jeff Mazik, Vice President, Life Science Solutions, AssurX With the close of t [...]

15 07, 2015

Will New User Fees Fuel More FDA Inspections?
Will New User Fees Fuel More FDA Inspections?

Will New User Fees Fuel More FDA Inspections?

By AssurX Blog|2015-07-15T08:25:57+00:00July 15th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Regulatory Compliance Management|

For FY 2016, FDA is requesting $4.9 billion to support our essential functions a [...]

14 07, 2015

FDA Warning Letters Hit Device Makers Over CAPA, MDR Failures

By AssurX Blog|2023-03-08T22:53:44+00:00July 14th, 2015|Archives, eMDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

It’s been a little while since we checked the FDA’s outgoing mail tray to find o [...]

30 06, 2015

Medical Device Makers Express Optimism About Future – But QA Worries About US Regulatory Burden

By AssurX Blog|2015-06-30T08:22:18+00:00June 30th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Crystal may be clear, but crystal balls, at least metaphorically, are certainly [...]

23 06, 2015

FDA 510(k) Approval Process Now Averages Over Six Months

By AssurX Blog|2024-12-31T23:56:42+00:00June 23rd, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

If you’ve got six months – and nerves of steel – here’s some good news: You hav [...]

19 06, 2015

FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting
FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting

FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting

By Tamar June|2025-05-19T19:01:30+00:00June 19th, 2015|Archives, eMDR, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Looks like it's crunch time for medical device manufacturers. Whether they subm [...]