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.

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

Are You Ready for 21st Century eMDR Submissions?
Are You Ready for 21st Century eMDR Submissions?

Are You Ready for 21st Century eMDR Submissions?

AssurX Blog2014-11-21T10:35:19+00:00November 21st, 2014|

Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been pr [...]

Medical Device Industry

Brookings Looks to Advance Medical Device Postmarket Surveillance System

FDA Gives MDDS World a Big Break

FDA Gives MDDS World a Big Break

Training Management Best Practices for Emerging Life Science Companies

Training Management Best Practices for Emerging Life Science Companies

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

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 Update on UDI Implementation for Registered Medical Device Establishments

FDA Update on UDI Implementation for Registered Medical Device Establishments

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

FDA FastStats: A Look Back at 2013 Medical Device 483 Observations

FDA’s Local Offices Flex Regulatory Muscle

Are You Ready for 21st Century eMDR Submissions?

Are You Ready for 21st Century eMDR Submissions?