ISO 13485 certified and ready!
Milestone 1 achieved: Decomplix is now officially ISO 13485 certified meaning we have the certified quality management system required to be a legal manufacturer. Decomplix is now ready to take on innovative developers and new entrants to bring medical device faster to the CE market. Our clients can then focus on their business development, innovation and marketing. Decomplix simplifies market access, in particular for medical apps and wearables, by shortening time-to-market substantially.