Medical Device QMS
Speed to Market
Maintaining compliance while fostering innovation at the speed required to compete on a global scale requires streamlined, agile quality processes that quickly close the loop on medical device quality problems.
It’s why big players in medical device recognize a critical need to implement automated medical device quality management system (QMS) software, which provides a competitive edge through enhanced standardization and a best-practices framework for continuous improvement.
An advanced medical device QMS offers compliance with regulatory standards such as Current Good Manufacturing Practices (GMP), 21 CFR Part 11 and Annex 11 and ISO: 13485, eMDR electronic form submission and more effective system validation