OK, you’re working away diligently on the requirements for your company’s slick new medical device (using Polarion’s Medical Device Solution, of course!) You feel you’re well up on FDA regulations for the United States, and you draft a major requirement accordingly. But the device will be sold in Europe and Japan too. Quick now: is your requirement compliant? The answer may be as close as your phone.
What they can’t do with Apps these days! The Emergo Group Medical Device Regulatory app claims to be a “valuable reference tool for medical device Regulatory Affairs (RA) and Quality Assurance (QA) professionals.”
According to the AppStore page, this iOS app delivers “quick access to global medical device regulations, daily medical device regulatory updates, contact information for 60+ Ministries of Health and Certification Bodies. Also the full text of the US FDA QSR (Quality System Regulation, 21 CFR Part 820) plus full text of the Medical Devices Directive – MDD 93-42-EEC.” And it goes on to list the 12 countries the app covers.
We’re wondering if anyone in the Polarion community working in medical device development is using this app? If you are, what’s your experience with it? Please post a comment!