Information for today’s Regulatory Professional
Welcome to RIMtelligence, a monthly info-Blog that you’ll surely want to bookmark.
We invite you to follow our subject matter experts as they share useful information about key industry regulations along with insights about how organizations are improving the efficiency of regulatory operations information management.
Theranos Loophole Explained
Should increased scrutiny be applied to the oversight of laboratory developed tests?
Black Friday
Why is your regulatory data stored in regional silos? Why is there a requirement for inter-departmental data requests? Why does it take 3 days, 3 weeks, 3 months to find what you are looking for? Why must the regulatory team triple check spreadsheets for data accuracy? Why are weekly registration update meetings scheduled throughout your …
Eye of the MDR Storm
The predictions of an apocalyptic melt down of the medical device industry has not (yet) come to fruition
Actor ID v SRN
The MDCG has issued additional guidance for registration of “other” actors in EUDAMED
Legacy Device Challenges
To date, no horsemen of the apocalypse or world annihilating meteor strike has befallen the medical device industry. However, the continued management of MDD legacy device data is an altogether different cataclysm.