Skip To Main Content
regulatory. He on Muck Rack

regulatory. He

As seen in: MedTech Intelligence
Is this you? As a journalist, you can create a free Muck Rack account to customize your profile, list your contact preferences, and upload a portfolio of your best work. Claim your profile
Back to regulatory. He’s profile

Articles by regulatory. He

What Are the Biggest Changes under EU MDR?

|
By Jon Speer, regulatory. He
| MedTech Intelligence
The compliance deadline for the new EU MDR is right around the corner. With new regulations come new processes affecting medical device companies. Time is of the essence with nearly one month remaining, and manufacturers still have much to consider before the deadline. But which of the changes under EU MDR are impacting companies the most? And what is the best way to respond?
Open in Who Shared Issue with article?

Why You Must Have a Single Source of Truth for CAPA

|
By Jon Speer, regulatory. He
| MedTech Intelligence
Corrective and Preventive Action (CAPA) is a major process that lives within the quality system of medical device companies. It is used by quality professionals to investigate and solve issues, identify reasons for fault, and initiate actions to understand the cause and prevent recurrence of issues found. Yet, year after year CAPA remains one of the top reasons for FDA to issue 483 observations, typically due to inadequate processes or inconsistent adherence to regulatory requirements.
Open in Who Shared Issue with article?
Show More