Author: Silas Minnick, Senior Quality Engineering Consultant With the release of ISO 14971:2019 and ISO/TR 24971:2020, medical device manufacturers are…
Challenge: Eximis Surgical sought assistance in taking their startup from the early stages as an R&D company to implementing an…
Guest Author: Tasha Bond, Founder of Ikigai Medical Development and COO of Sana Health, Inc. Many medical device manufacturers relegate…
Author: Jerry Sudduth, Regulatory Consultant The EU Medical Devices Regulation (MDR) Date of Application (DoA) takes effect today. Do you understand…
Guest Author: Ali Gallagher, J.D. Non-compliance with FDA regulations can not only delay your product getting in the hands of…
Austin, TX, May 19, 2017 – QA Consulting announced today that it has received ISO 13485:2016 certification to provide medical…
The FDA issued a long-awaited final guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part…