I work in a 200-person Class II medical device company with two QA/RA folks, three embedded-hardware teams, a small supplier-quality group, and engineers who want automation — not more paperwork. We needed an eQMS that unifies design control (DHF), CAPA, supplier records, and traceability into something engineers will actually use. I evaluated several vendors and want to share a short, practical …
Research from academic institutions is a significant driving force in developing new medical devices. In 2020, the Association of University Technology Managers (AUTM) reported 27,112 invention disclosures [1]. Despite these impressive efforts, disclosures do not translate into commercialized products due to numerous barriers, including weak support infrastructure and the lack of institutional kn…
