Many medical device manufacturers and developers (including us) use agile principles to develop medical devices. Done properly, medical devices can be developed more efficiently while still meeting guidance, standards, and regulations. Unfortunately, many companies don’t do enough to ensure design controls are appropriately implemented when using agile during product development… whether it’s just for software, or the entire product development process. At the INCOSE Conference on Agile Systems in Healthcare on May 23 and 24, we’ll be presenting our direct experience with the FDA and medical device manufacturers. What does an inspector think of agile? How have medical device companies done it right (and wrong)? We’ll answer questions like this and have an open discussion on efficient, real-world implementation of agile in healthcare. Join us!
We’ve kicked off company operations in March. It’s been a long time coming! One of our first tasks is to wrap up our Quality Management System (QMS). Lucky for us, ISO 13485:2016 has finally been published. I like the changes– they provide more detail around some critical activities like verification and validation, and ensure risk management is used throughout the QMS. ISO 13485 has begun its divergence from ISO 9001!
No notified bodies are certifying to the 2016 version at the moment, but we’re going to bake it into our QMS to ensure we’re ready to roll when the time comes. Along with conforming to ISO 13485 (2003 and 2016), we conform to 21 CFR 820 and the Canadian Medical Devices Regulations (SOR 98-282).