Why software design tools make excellent business sense
This article was originally published in Clinica
Executive Summary
Regulators need to keep up to speed with the rapid developments in medical device software. The FDA has just strengthened its software guidance and the EU is also in the process of tightening software requirements in the Medical Devices Directive review. These developments make a compelling case for manufacturers to use software design tools that automatically generate much of the required regulatory documentation, including for premarket submissions argues consultant Trevor Lewis and associates.*
You may also be interested in...
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Novartis Hires Ex-BMS Chief As It Pursues US Growth Strategy
The Swiss pharma company is looking to tap into the experience of ex-BMS leader Giovanni Caforio to help further it US-first commercial strategy.
Maxwellia Delivers Two UK Menstrual Health Rx-To-OTC Switches
UK switch specialist Maxwellia delivers two “me too” reclassifications in the area of women's health: Evana Heavy Period Relief and Ultravana Period Pain Relief.