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.

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

Tamar June2015-04-28T07:14:17+00:00April 28th, 2015|

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

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

FDA Works to Clarify Device Data Collection Priorities

AssurX Blog2025-05-19T19:08:28+00:00April 20th, 2015|

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

FDA Plays Catch Up In Brave New World of Electronic Consent
FDA Plays Catch Up In Brave New World of Electronic Consent

FDA Plays Catch Up In Brave New World of Electronic Consent

AssurX Blog2025-05-19T19:09:27+00:00April 9th, 2015|

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

Brookings Looks to Advance Medical Device Postmarket Surveillance System

AssurX Blog2025-05-19T19:10:41+00:00March 11th, 2015|

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

FDA Gives MDDS World a Big Break
FDA Gives MDDS World a Big Break

FDA Gives MDDS World a Big Break

AssurX Blog2025-05-19T19:11:41+00:00March 2nd, 2015|

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

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

AssurX Blog2024-07-16T22:25:22+00:00February 4th, 2015|

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

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

Tamar June2015-01-14T09:55:01+00:00January 14th, 2015|

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

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

Tamar June2014-12-30T15:38:32+00:00December 30th, 2014|

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

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

Tamar June2025-10-02T22:45:31+00:00December 19th, 2014|

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

FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies

Tamar June2014-12-03T10:19:41+00:00December 3rd, 2014|

FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality S [...]