Sep 25, 2019 | Medical Devices, On Demand Webinar
FDA’s shift to a Quality System Regulation structure of ISO 13485:2016 is an effort to harmonize medical device regulations as well as reduce compliance and record keeping burdens faced by current medical device manufacturers. But will those …
May 1, 2019 | Ask the Expert, EASeNews, Medical Devices
By George Yanulis Each month, EAS selects one question sent in by readers to be answered by one of our experts. This month’s question is answered by George Yanulis D.Eng., an expert in medical device safety and the 510(k) process. Question: Why is FDA proposing to...
Mar 1, 2019 | Who’s Who at EAS
Dr. George Yanulis has consulted in Medical Device Product Development and Research for 20 years and has a Doctorate and Master’s Degree in Biomedical Engineering. He has conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing...
