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.

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

By AssurX Blog|2023-03-08T23:22:33+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 [...]

9 04, 2015

FDA Plays Catch Up In Brave New World of Electronic Consent

By AssurX Blog|2023-03-08T22:50:31+00:00April 9th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Regulatory Compliance Management|

Informed consent (IC) is more than getting a quick signature from a clinical tri [...]

11 03, 2015

Brookings Looks to Advance Medical Device Postmarket Surveillance System

By AssurX Blog|2023-03-06T20:13:18+00:00March 11th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Patients and medical device innovators will benefit if the United States is able [...]

2 03, 2015

FDA Gives MDDS World a Big Break

By AssurX Blog|2023-03-08T21:39:11+00:00March 2nd, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Sometimes it’s nice to be told what the FDA isn’t going to do. The agency issued [...]

4 02, 2015

Training Management Best Practices for Emerging Life Science Companies
Training Management Best Practices for Emerging Life Science Companies

Training Management Best Practices for Emerging Life Science Companies

By AssurX Blog|2024-07-16T22:25:22+00:00February 4th, 2015|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management|

No matter how good your written policies are, or how clean a facility you operat [...]

14 01, 2015

FDA’s CDRH Guidance Tempers 2015 Goals with a Dash of Pessimism

By Tamar June|2015-01-14T09:55:01+00:00January 14th, 2015|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

Unlike its sister Center for Drug Evaluation & Research (CDER), CDRH’s (Cen [...]

30 12, 2014

FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014
FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014

FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014

By Tamar June|2014-12-30T15:38:32+00:00December 30th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry|

FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for the Fisc [...]

19 12, 2014

FDA Update on UDI Implementation for Registered Medical Device Establishments
FDA Update on UDI Implementation for Registered Medical Device Establishments

FDA Update on UDI Implementation for Registered Medical Device Establishments

By Tamar June|2024-07-29T23:51:05+00:00December 19th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Regulatory Compliance Management|

In case you missed it, the FDA issued this update on UDI yesterday: Having passe [...]