NSF's Trautman Talks MDSAP, Swapping FDA's QSR For ISO 13485, Regulatory Convergence, EU's MDR & IVDR, And More
• By Shawn M. Schmitt
Former longtime US FDA official Kim Trautman, now with NSF International, sat down with Medtech Insight at MedCon 2018 for a podcast interview to discuss an array of industry issues, including the burgeoning Medical Device Single Audit Program, international regulatory convergence, FDA's percolating plan to replace the Quality System Regulation with ISO 13485, what keeps her up at night (hint: it's EU's new Medical Device and IVD Regulations), and other important issues that device-makers need to keep a sharp eye on.
When it comes to understanding the intricacies of international regulatory issues and possessing high-level quality systems knowledge, former US FDA official Kim Trautman may be second to none.
Early on in her career at the agency – between 1991 and 1996 – Trautman crafted the Quality System Regulation, which has been the bedrock rule for making safe and...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
