Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

FDA warning letter data reveals the same top 10 compliance issues have plagued medtech for 20 years, with CAPAs leading at 12 ...

FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing the ...

In this free webinar, learn how medical devices benefit from modern digital validation strategies. Attendees will learn how digital validation builds confidence and removes redundancy. The featured ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

With Covid accelerating time-to-market for medical devices, digital tools play a key role in managing converging priorities ...

Medical device manufacturing is a high-stakes game where efficiency meets precision. With tight regulations, complex designs, and a need for speed, how do companies stay ahead without cutting corners?

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...

Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...

Explore how enterprise-grade EHR integration services accelerate medical device innovation by enabling seamless data exchange ...