Sep 26, 2023 | White Paper
Want to learn more about the importance of effective supplier controls and management in the context of medical devices? You’re in the right place! This White Paper covers the different aspects of supplier quality management including: the fundamental role of...
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...
May 1, 2023 | White Paper
Whether you are a start-up company or a well-established business, auditing is not only an integral part of the business process, but also a requirement. Knowing the right timing to implement the quality audit program within the quality system lifecycle and how audits...
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!...
