AssurX Blog
Straight talk for regulated industries.
FDA Issues Deadline Reminder to Medical Device Companies on Electronic Medical Device Reporting
Looks like it's crunch time for medical device manufacturers. Whether they submit one or 10,000 medical device reports (MDRs) to the FDA per month, they are required to go all electro [...]
FDA’s Shuren Works to Assure Device Industry Innovators
Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approva [...]
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 [...]
