In this episode of Chasing Compliance, host Jamie Hijmans sits down with John Jolly, a Manager in Global’s Medical Device Department to discuss medical device post-market surveillance (PMS). Over the course of the episode, John and Jamie discuss John’s path from biomechanical engineer to PMS guru, the value of academic research experience in the world of regulatory affairs, what PMS is and why it matters, and the differences between the United States and European Union. Perhaps most importantly, John discusses what the pending European Union Medical Device Regulation (MDR) means for manufacturers in terms of PMS, and he provides a brief overview of 7 aspects of PMS that are going to be affected by the beefed-up regulations. On the lighter side, John and Jamie wrap up the episode with recurring segment, Favorite Friday Nights. John talks about movie night with his family and how working from home has improved his quality of life.
This is part 1 on our conversation on optimizing clinical site selection and evaluation. In this episode Linda Peterson and Julie Sheidy provide some...
This episode of Chasing Compliance is for those working on regulatory submissions for in-vitro diagnostic (IVD) medial devices. Today we talk to our resident...
This episode of Chasing Compliance features two first-hand accounts of what it was like to participate in the Global Clinical Evaluation Report (CER) Internship...