Tamar June: President and CEO of AssurX

Tamar June, President and CEO of AssurX, leads the company with a vision for innovation in quality management and compliance solutions. Her leadership drives AssurX’s commitment to providing cutting-edge technology that enhances operational efficiency and regulatory adherence across industries.

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 [...]

3 12, 2014

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

By Tamar June|2014-12-03T10:19:41+00:00December 3rd, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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

25 11, 2014

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

By Tamar June|2014-11-25T10:40:05+00:00November 25th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

FDA FastStats: A Look Back at 2013 Medical Device 483 Observations: As we approa [...]

24 09, 2014

FDA Proposals Take a Fresh Look at Some Stale Food Issues

By Tamar June|2024-06-25T18:27:54+00:00September 24th, 2014|Archives, FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management, Risk Management|

That landmark Food Safety Modernization Act (FSMA) just keeps getting more and m [...]

17 09, 2014

The FDA is Reading Your Facebook Page and They Don’t ‘Like’ What They See

By Tamar June|2014-09-17T13:49:20+00:00September 17th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Regulatory Compliance Management|

In a previous post we looked at the FDA's relatively ho-hum guidance on social m [...]

19 02, 2014

CDRH 2014 Strategic Priorities Promise Improved IDE, PMA Regulatory Climate

By Tamar June|2023-03-08T22:39:49+00:00February 19th, 2014|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The Center for Devices and Radiological Health or CDRH will focus on encouraging [...]