AssurX Blog
Straight talk for regulated industries.
FDA Moves UDI Initiative Further Down the Production Line
We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. But it’s only fair to give equal space to something when [...]
Large Utilities Power Up with AssurX Enterprise GRC Solution
Increasingly complicated, and disparate, regulatory requirements and a demand for improved compliance management were driving forces. These factors led two major utility companies to f [...]
Big Pharma Goes Big for Big Data
When it comes to data, big pharma knows what big pharma likes, according to a new survey of giant pharmaceutical companies that included AstraZeneca, Merck, Pfizer and Boehringer Ingel [...]
Congress Crawls Out of 20th Century to Push Bi-partisan ‘Cures’ Legislation
Just when we'd all decided Washington lawmakers couldn't do much more than enjoy their own excellent health insurance coverage, tasty bean soup in the Senate cafeteria, and the best pa [...]
Should FDA Get Tougher on IRBs?
Patrick Stone, President, TradeStoneQA The FDA says IRBs (Investigational Review Boards) are not required to collect a statement of investigator assurance from studies they preside o [...]
Avoid Common Medical Device Software Development Life Cycle, IEC 62304 Pitfalls
IEC 62304, the international standard that defines software development lifecycle requirements for medical device software, was developed from the perspective that product testing alon [...]
