BLOG
Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
FDA 510(k) Approval Process Now Averages Over Six Months
If you’ve got six months – and nerves of steel – here’s some good news: You have a 61% percent chance of getting your m [...]
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 [...]
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 Sh [...]
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 f [...]
Large Utilities Power Up with AssurX Enterprise GRC Solution
Increasingly complicated, and disparate, regulatory requirements and a demand for improved compliance management were dr [...]
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 compani [...]
