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
Manufacturers need to evaluate their approach to preclinical testing. Avoiding contradictory study design is the most effective path forward for study sponsors.
Mark R. Cunningham, Ph.D., Senior Director of Science and Technology, Technical Services, WuXi AppTec 08.11.20
Legislators in Washington are keenly focused on both the upcoming national election on Nov. 3 and addressing the healthcare challenges during a pandemic.
Jeffrey J. Kimbell, David C. Rudloff, Caroline P. Tucker and Matteson L. Beckis, Jeffrey J. Kimbell & Associates Inc. 08.11.20