Medace supports academic groups and companies with innovative medical concepts in need of technical, quality and clinical expertise. Bringing along a broad network, we help you to successfully develop your product into the clinical phase.
With our proven pick-and-choose concept we provide you clinical product development compliant with the latest ISO and GMP standards.
Our specialists work together with you and your team in a fully equipped and state of the art biomedical co-working space – whenever it suits you.
What will you achieve?
Who do we work with?
Our biomedical co-working space is open to academic groups and companies working in the field of medical devices, ATMPs and regenerative medicine.
Imagine how future patients may benefit from your promising biomedical concept. Find the best way to transfer your innovation out of the academic setting into patients. Situated in the heart of a medical hub we offer you the perfect surroundings to succeed.
Medical devices companies
With an overarching ISO-13485 compliant Quality Management System we offer you a QMS that you can base your development processes on. We offer a proven method of self-control and responsibility over your own product and professional technical, quality and regulatory guidance.
Cell therapy companies
Prepare your ATMP – in compliance with Eudralex 4- at Medace, offering you a full service GMP-ready site with cleanrooms grade B/C and cell culture labs. Other ATMP clients have already proven our concept to be successful by obtaining their GMP Manufacturing License at Medace.
Regenerative medicine companies
Regenerative medicine converges biomedical research, innovative technology and patient care. With our broad knowledge of quality, materials and cells you are equipped to develop your concept of using our body’s own resources to regenerate and repair damaged tissues
Our comprehensive development process ensures a smooth transition from product definition and proof of concept through quality management, clinical trial and CE or EMA (/FDA) approval.
Step 1: Product definition
Focus on product development, technology development and user requirements. You will also take the first steps in Quality management: develop design inputs. At the end of this phase you will have your proof of concept Prototype.
Step 2: Engineering detailed design & development
You will now start to develop a Regulatory Strategy and a Manufacturing Strategy (vendor selection). Together with the necessary SOP’s and detailed processes you will further build up your Quality Management System.
Step 3: Transfer
Finished the usability engineering and technology development, now working on your clinical product.
- Product development: Work instructions
- Quality:Approval Device Master Record (DMR)
- Regulatory: Submission
- Manufacturing: Validation
Step 4: Manufacturing
Now working on full clinical products.
- Product development: Sustaining engineering
- Quality: Implement QMS
- Regulatory: Approval and certification
- Manufacturing: Volume manufacturing