Learn the world of clinical manufacturing

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.

More about Medace

What will you achieve?

A medical product that meets all the necessary quality demands for clinical application

A product specific Quality Management System

Reduced product development investments by sharing laboratories, equipment and cleanrooms

Up to date knowledge of regulatory affairs and quality assurance

On the job Coaching by trained professionals

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.

Academic groups

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 with 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.

Timeline

Our comprehensive development process ensures a smooth transition from product definition and proof of concept through quality management, clinical trial and CE or EMA 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.

Main tasks:

Product development: Work instructions
Quality:Approval Device Master Record (DMR)
Regulatory: Submission
Manufacturing: Validation

Step 4: Manufacturing

Now working on full clinical products.

Main tasks:

Product development: Sustaining engineering
Quality: Implement QMS
Regulatory: Approval and certification
Manufacturing: Volume manufacturing

Let’s meet!

Interested to join our community? Got some questions you want answered? Thinking of creating your own space at Medace?

Plan your meeting with CBO Kurt Gielen now.

Let's meet Get in touch