Blog2025-03-18T10:11:14+00:00

AssurX Blog

Straight talk for regulated industries.

907, 2019

AssurX Announces Patch Management Software for Greater IT and OT Asset Cybersecurity Control

July 9th, 2019|AssurX News + Success Stories, Energy & Utilities Industry, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, NERC Compliance, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Process-based Patch Management solution turns awareness into action Morgan Hill, CA., July 9, 2019 – AssurX, Inc., a leader in enterprise quality management and regulatory compliance s [...]

2506, 2019

EU MDR Rules Could Impact Medical Device Business Strategies

June 25th, 2019|FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Changes in the European Union (EU) MDR and IVDR standards could force business change in the EU’s MedTech market. The second-largest market for medical devices is about to go through a [...]

1906, 2019

TEDOR Pharma selects AssurX Quality Management Software to Automate and Streamline Processes

June 19th, 2019|AssurX News + Success Stories, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

TEDOR expects to gain operational efficiencies for future growth using the AssurX platform Morgan Hill, CA., June 19, 2019 – AssurX, Inc., a leader in enterprise quality management sof [...]

1806, 2019

FDA to Sunset Alternative Summary Reporting (ASR) Program

June 18th, 2019|eMDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible. The ASR program originally [...]

3005, 2019

Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest

May 30th, 2019|FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

FDA regulation 21 part 822 lays out the process, the rules, and the products that require postmarket surveillance. The process is an active, systematic, scientifically valid method of [...]

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