Too many promising medical innovations never reach the market or the patient. One of the hurdles to take is finding your way through the ever more stringent and difficult landscape of medical devices and cell therapy (GMP) legislation and technical validation.
Medace offers a full service medical development work-learning environment. Here, our customers (academics or entrepreneurs) are guided and serviced in setting up and developing their product’s technical dossier whilst producing their clinical grade product in house themselves.
Medace works with an EN ISO 13485:2016 certified quality and service package available for our customers on a use by need basis:
- Specialized infrastructure (e.g. ISO7 and 8, and Class C and B cleanrooms)
- Validated and specialized equipment
- Quality Management System
- Trained professionals for hands-on guidance and support during development and validation
- Dedicated in-house training programs
Interested in our services and eager to learn more? Contact us via firstname.lastname@example.org