Where do you want to be 10 years from now? How do you plan to get there? By focusing on being a catalyst, making connections, and creating value through product and services, you can establish a strategy that will yield success through 2020 and beyond. Contact us to learn how we can help you! … Read More
December 10, 2013
UniDoc is the collaborative way to manage design history for all your medical device projects. Whether you have one or one hundred. Imagine FDA shows up and wants to review the design history file (DHF) for one of your devices. Can you find it? Is it complete? Rather than dump your design control documentation and [...]
December 8, 2013
If you have been a part of medical device product development, there is a good chance you are somewhat familiar with the image below: Most refer to this as the FDA Design Control waterfall diagram (the origin is actually Health Canada) and is referenced in FDA Design Control Guidance document. Since starting my career as [...]
Copyright © 2013 • Creo Quality: Catalyst. Connect. Create.