Global Medical Device Podcast Powered By Greenlight.guru

Change is constant… Especially in the medical device industry. Medical device change management can be a challenging concept and process for companies, especially during FDA inspections and other audits from regulatory agencies. Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss the twists and turns of what to expect, what you may experience, and what to focus on when dealing with change management. Some of the highlights of the show include: - Do’s and Don’ts of Change Management: Depends on device class and complexity, as to how stringent communication and reporting is required. - Change Management Options: Notify FDA or do not notify FDA of change. The information is the same, but what a company does with it is different. - Letter to File: Documentation describing change, why it’s being made, testing conducted to determine no impact on safety, efficacy, and performance to device. - With a change, avoid marking up documents before performing a preliminary engineering