Navigating automation, robotics, AI, and data in a QMSR-driven manufacturing world

We spend a lot of time with manufacturing leaders, quality teams, and in-house counsel who are all talking about the same basic issue, just from different angles: automation, AI, data, and how far to push “digital transformation” in a regulated environment. From our perspective as FDA lawyers focused on medical devices, and as ISO 13485 auditors, the question is no longer whether these tools are coming. They are already here. The real question is how to use them without creating a validation... By: Hogan Lovells