Adverse Event Handling Solutions by AssurX

AssurX streamlines adverse event handling with automated processes for intake, investigation, and regulatory reporting. Our solution ensures accurate data collection, compliance with FDA requirements, and efficient communication across departments. Enhance your organization’s ability to manage incidents swiftly and effectively, reducing risks and maintaining high safety standards.

18 06, 2019

FDA to Sunset Alternative Summary Reporting (ASR) Program
FDA to Sunset Alternative Summary Reporting (ASR) Program

FDA to Sunset Alternative Summary Reporting (ASR) Program

By AssurX Blog|2023-03-08T23:16:10+00:00June 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 [...]

30 05, 2019

Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest
Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest

Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest

By AssurX Blog|2024-11-20T20:17:20+00:00May 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 th [...]

16 12, 2016

Risk Management + Adverse Event Reporting: FDA Guidance
Risk Management + Adverse Event Reporting: FDA Guidance

Risk Management + Adverse Event Reporting: FDA Guidance

By AssurX Blog|2016-12-16T10:21:33+00:00December 16th, 2016|Archives, eMDR, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Risk management and adverse event reporting protocols for medical device manufac [...]