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MDR

26 05, 2022

EU Medical Device Regulation Still Presents Challenges and Opportunities
EU Medical Device Regulation Still Presents Challenges and Opportunities

EU Medical Device Regulation Still Presents Challenges and Opportunities

By Sal Lucido|2022-05-26T09:04:58+00:00May 26th, 2022|EU IVDR, EU MDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]

5 05, 2021

All Roads Lead to ISO 13485: The Global Context
All Roads Lead to ISO 13485: The Global Context

All Roads Lead to ISO 13485: The Global Context

By AssurX Blog|2021-05-05T07:16:06+00:00May 5th, 2021|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

As regulations and standards evolve, one trend is continually sharpening in focu [...]

21 01, 2021

EU MDR Countdown: What’s Next for Medical Device Compliance
EU MDR Countdown: What’s Next for Medical Device Compliance

EU MDR Countdown: What’s Next for Medical Device Compliance

By AssurX Blog|2021-01-21T08:00:47+00:00January 21st, 2021|eMDR, EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

In four months, the new EU Medical Device Regulation (MDR) goes into effect, whi [...]

19 01, 2021

Addressing the EU MDR and IVDR Certification Bottleneck
Addressing the EU MDR and IVDR Certification Bottleneck

Addressing the EU MDR and IVDR Certification Bottleneck

By AssurX Blog|2021-01-19T07:00:36+00:00January 19th, 2021|EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

With the May 26, 2021 implementation deadline looming for the new EU Medical Dev [...]