Fragmented processes, lack of traceability, and the infamous compliance wall can slow you down, or even block your path to market entirely. It’s no wonder medical device teams feel overwhelmed about launching their device.
But what if you could avoid these obstacles altogether?
Our design control software is designed to manage your design control documentation and traceability in compliance with ISO 13485:2016 and FDA 21 CFR 820, cutting out rework, delays, and missed timelines. And with all your information and processes centralized on one platform, you’ll be audit-ready, no matter when an inspector comes knocking on your door.
