If you are like most medical device companies, the term “design control” is usually met with a cringe or two. I also suspect your product development process and design control deliverables might be more cumbersome and quirky than you’d like–especially since you are expected to complete your medical device product development efforts as quickly as possible.
And what happens once the product development project is complete? Do you file the design control records away in a design history file (DHF) and archive them in some file cabinet or electronic record system? How easy are these to retrieve and access for future projects? Do other groups, such as regulatory affairs have access to DHFs in order to compile regulatory submissions such as 510(k)s and technical files?
What if you had a software solution to document design controls as they happen? What if this same solution could be a living repository for all design control and product development activities? What if this same solution could also pre-populate regulatory submissions?
Don’t think this product exists? Think again. Creo Quality’s UniDoc software is the solution you need to streamline your medical device product development efforts.
UniDoc is developed from proprietary database platform software and be mapped to match your current product development and design control processes. The software is 21 CFR part 11 compliant and meets FDA, EU, and Canadian regulations for medical device design controls. UniDoc contains modules for key regulatory submissions, including FDA 510(k), FDA IDE, EU technical file, and Canadian submissions.
If you are interested in learning more about UniDoc and how you can get this product at your company, contact us: info@creoquality.com or 765 315 2736.
