Medace BV Information

By sharing expertise, infrastructure and equipment, we improve product quality, increase efficiency and reduce costs. Medace accelerates the road from Patent to Patient. Together. Too many promising medical innovations never reach the patient due to ever more stringent and difficult landscape of medical devices and cell therapy (GMP), legislation and technical validation. Medace is committed to bring your innovative (bio)medical concepts to the market and patients faster. Medace offers a full service work-learning environment where academics and entrepreneurs are guided in how to set up and develop the technical dossier needed for clinical validation whilst producing their clinical grade product. We have an overarching quality management system in place, specialized infrastructure (12 cleanrooms, grade D to B), validated equipment and dedicated training program and trained professionals for hands-on guidance and support. The concept is wholly in scope of the certification according to the latest Medical Device QMS Standard (ISO 13485:2016) and can be used by our customers to obtain their GMP Manufacturing License.