Content by Etienne Nichols
What FDA QSR and ISO 13485 Harmonization Means for Medical Device CompaniesQuality management system regulation explained
Mon, 03/28/2022 - 12:03
On February 23, 2022, the FDA released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality…
Best Practices for an Effective Medical-Device Design Transfer ProcessMore than passing a baton
Wed, 01/19/2022 - 12:01
If you’re looking for information on medical-device design controls and product development, you can find a practically endless number of articles, videos, and podcasts with a few quick online searches. Yet with so much out there on these topics,…
5 Key Elements of an Effective CAPA SystemCommon challenges medtech companies face, and how to overcome them
Wed, 06/25/2025 - 13:33
The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS). The goal of the CAPA system is to identify, address, and prevent systemic issues that could…