Medace
Driving Medical Innovation from Patents to Patients

Medace is revolutionising the medical industry by teaching and guiding inventors and emerging entrepreneurs how to get their innovative medical products to patients more quickly. With its unique work-learning production facility and understanding of the challenges of navigating the complex and time-consuming regulatory compliance procedures, it empowers early-stage medtech and biotech companies to develop their medical products themselves.

Medace has established a collaborative medical production facility that fully complies with European regulations. This environment serves as a platform where Medace collaborates with emerging entrepreneurs and provides them with the necessary training and support. It proactively guides them to develop their product dossier, quality system, and production process. The uniqueness comes from the ISO certified and GMP compliant quality management system which serves as a template for client’s own quality management system. This template quality management system enables clients to avoid starting from scratch, instilling confidence that they are following the best practices.


Medace itself is certified according to the ISO 13485 standard, which reflects its absolute commitment to quality. This certification serves as an assurance to clients that it has extensive experience traversing the diverse quality and regulatory compliance landscape.

It is all made possible through its substantial cleanroom facility spanning over 2,100 square meters, completely dedicated to medical devices and GMP, with a particular focus on Advanced Therapy Medicinal Products (ATMP) and regenerative medicine. The facility includes five medical device cleanrooms and six GMP cleanrooms, providing ample space for production activities.

In addition, adjacent Quality Control and Development Labs are available for mechanical testing and cell biology research.

“Our Quality Control and Development Labs plays a critical role in ensuring the products developed by entrepreneurs are tailored to meet the necessary requirements for production. We also provide a platform for refining product development and optimising the production process, as well as conducting mechanical testing and cell biology research,” says Danielle Curfs, CEO of Medace.

But its expertise extends beyond quality regulatory compliance. The insights it shares with clients come from years of experience and working with a diverse range of clients. “This experience has allowed us to provide tailored support in multiple areas, including product development, manufacturing, quality assurance, and regulatory compliance,” says Kurt Gielen, chief business officer, Medace.

In one instance, Medace helped a medical device company achieve ISO certification shortly after Medace did. The quality inspector noted that most items in the client’s quality management system had already been inspected as part of Medace’s mandates, which allowed for a more focused and less time-consuming inspection of the specific product and its requirements. Following this, the client got their certification and was able to move on to building their own facility and is currently conducting clinical trials.

Our Quality Control and Development Labs plays a critical role in ensuring the products developed by entrepreneurs are tailored to meet the necessary requirements for production

One of the significant advantages of working with Medace is that entrepreneurs maintain control over their product development process from start to finish. Unlike outsourcing to a third party, which can result in a loss of control at certain phases, Medace’s approach empowers entrepreneurs’ ownership in their product’s development, ensuring they can make informed decisions along the way.

This approach also facilitates lower capital expenses, enabling entrepreneurs to test their products in a clinical setting without making significant financial commitments. It allows emerging entrepreneurs to determine their product’s viability in the market and generate valuable evidence to present to potential investors. This is particularly critical when seeking Series A funding.

Relieving clients from getting stuck in the regulatory approval stage and slowing down the development process, Medace’s cost-effective, low-risk approach is a boon for early-stage medical and medicinal innovators.