Jul 31, 2023 | White Paper
Unleash the Future of Medical Device Coding: Mastering IMDRF Adverse Event Codes! Step into a cutting-edge world of medical device coding, where the power of IMDRF Adverse Event codes revolutionizes patient safety. Join the FDA and EU as they embrace this approach,...
Jun 19, 2023 | White Paper
Are you in the early stages of design development of a product? Or do you need help remediating your Design History File? This White Paper will provide guidance on the global requirements of design control and the documented evidence needed to meet global regulatory...
Mar 20, 2023 | White Paper
It is so important to develop your Quality Management System (QMS) around: your medical products, your organizational structure, your company’s maturity, and your global strategy. Both FDA’s Quality System regulation and ISO 13485:2016 give you this flexibility!...
Feb 6, 2023 | White Paper
Determining the right size of a Quality Management System (QMS) can make some feel like they are on a roller coaster ride and not know how to navigate the numerous drops and turns. Although developing a QMS is a requirement, it does not need to be overwhelming....
