The EU Medical Device Regulation (MDR) has certainly caused significant impact to the medical device industry. Regulatory and quality professionals are still learning some of the nuances, and with the ...
The EU clinical trial landscape has changed significantly since Regulation (EU) No 536/2014 became applicable on January 31, ...
LE MONT-SUR LAUSANNE, Switzerland--(BUSINESS WIRE)--Regen Lab, a global commercial-stage medical technology company specializing in the research, development, registration, manufacturing and ...
Compliance with the Medical Device Regulation (EU) 2017/745 (MDR) presents many new challenges to Medical Device manufacturers. Our in-depth MDR training is designed to help you and your team prepare ...
HOUSTON--(BUSINESS WIRE)--InGeneron, Inc., a biotechnology company pioneering autologous regenerative cell therapies, today announced receipt of a CE Certificate (No. 28620235524 issued January 19, ...
GARDNER, Mass., June 19, 2017 /PRNewswire/ -- The new Medical Device Regulation places a greater emphasis on clinical evaluation and clinical investigations as part of the conformity assessment ...