WOUNDCOM is composed of a bovine collagen I scaffold with addition of synthetic collagen VI peptides. WOUNDCOM will be regulated as a class III medical device according to the Medical Device Regulation (EU 2017/745). As a subject to regulation by MDR WOUNDCOM is required to have clinical evidence. The clinical evidence will ensure that patients and medical professionals will benefit from a product that is proven safe and efficient. The official evidence for this proven safety and efficacy is the CE mark that will be received from COLZYX designated Notified Body.
As part of the route to CE mark for WOUNDCOM, COLZYX is highly dedicated to implement and work according to the requirements for a Quality Management System in MDR and ISO 13485. As a first confirmation of the good work an ISO 13485 certificate will be obtained.