Blog2022-01-15T20:42:38+00:00

AssurX Blog

Straight talk for regulated industries.

302, 2021

Foster Delivery Science Implements AssurX Quality Management and Regulatory Compliance Software

February 3rd, 2021|AssurX News + Success Stories, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Quality Management|

AssurX Platform Automates Document Management and Training Management; More Processes Planned MORGAN HILL, CA, UNITED STATES, February 03, 2021 -- AssurX, Inc. (AssurX), a leader in qu [...]

2101, 2021

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

January 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, which officially means it’s crunch time for devices that need to be certified to the new law. What should c [...]

1901, 2021

Addressing the EU MDR and IVDR Certification Bottleneck

January 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 Device Regulation (MDR), medical device companies are under pressure to ensure products are compliant with [...]

1101, 2021

EU MDR Compliance Check-in: Challenges and Action Items

January 11th, 2021|EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The new EU Medical Device Regulation (MDR) goes into effect in less than six months, leaving little time for medical device manufacturers to bring products into compliance. The new law [...]

312, 2020

How to Meet New EU MDR Requirements for Vigilance and Reporting

December 3rd, 2020|Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

After a one-year delay due to concerns over a shortage of notified bodies, the new EU Medical Device Regulation (MDR) is set to take effect as of May 26, 2021. The regulations are a de [...]

2910, 2020

Revasum Implements AssurX Solution for Semiconductor Issue Management

October 29th, 2020|Manufacturing Industries, Quality Management, Regulatory Compliance Management|

FRACAS solution will help identify platform-based issues and drive reliability projects AssurX, Inc., a leader in enterprise quality management and regulatory compliance software, anno [...]

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