The FDA’s 2013 Unique Device Identification (UDI) Rule sets specific requirements for medical device labeling to improve traceability and patient safety.
Beth Wells, Senior Director, Community Engagement, Healthcare, GS1 US 02.08.21
This column focuses on the directive under EU 2017/745 on medical devices (MDR), highlighting some of the changes in claiming and demonstrating equivalence.
Cindy Boyer, Senior Manager, International Regulatory Affairs, MCRA LLC 11.18.20
Over the past 10 years, medtech manufacturers from startups to giants have grown their levels of outsourcing to contract R&D and manufacturing partners.
Maria Shepherd, President and Founder, Medi-Vantage 09.15.20