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.

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 [...]

18 06, 2015

FDA’s Shuren Works to Assure Device Industry Innovators

By AssurX Blog|2015-06-18T08:46:37+00:00June 18th, 2015|Archives, FDA Regulated Industries, Medical Device Industry|

Calling it something of a “culture change” at the Center for Devices and Radiolo [...]

10 06, 2015

FDA Moves UDI Initiative Further Down the Production Line

By AssurX Blog|2015-06-10T10:04:49+00:00June 10th, 2015|Archives, Medical Device Industry, Quality Management, Regulatory Compliance Management|

We, and others, like to take the FDA to task for missing deadlines or behaving i [...]

20 05, 2015

Congress Crawls Out of 20th Century to Push Bi-partisan ‘Cures’ Legislation

By AssurX Blog|2023-03-08T22:51:05+00:00May 20th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Just when we'd all decided Washington lawmakers couldn't do much more than enjoy [...]

30 04, 2015

Avoid Common Medical Device Software Development Life Cycle, IEC 62304 Pitfalls

By AssurX Blog|2024-06-03T13:21:35+00:00April 30th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Risk Management|

IEC 62304, the international standard that defines software development lifecycl [...]

28 04, 2015

FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR

By Tamar June|2015-04-28T07:14:17+00:00April 28th, 2015|Archives, eMDR, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline [...]

20 04, 2015

FDA Works to Clarify Device Data Collection Priorities
FDA Works to Clarify Device Data Collection Priorities

FDA Works to Clarify Device Data Collection Priorities

By AssurX Blog|2025-05-19T19:08:28+00:00April 20th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

A new FDA guidance issued by the Center for Devices and Radiological Health (CD [...]