Press release, 21 April 2020

Medace achieves ISO certification for product development in health care in record time

Medace is proud to display its ISO 13485:2016 certificate on the wall of its new biomedical facility today. This demonstrates that Medace has the strict procedures in place to act as a service provider for the production and distribution of implants and biomaterials. It is a quality mark in helping entrepreneurs and researchers get their medical innovation to the patient faster and an important step for Medace’s customers who make use of the shared learning and working environment. They can be confident that quality has the highest priority.

Service model for healthcare product development

pic Medace ISO

Leah Evers, Quality Assurance manager at Medace

The service model that Medace uses is more than distinctive. Rarely has a model based on sharing infrastructure, knowledge and skills been rolled out in a critical market such as healthcare product development. The model was developed by Medace employees within the Chemelot Institute for Science & Technology (InSciTe), where it was tested and validated on a small scale. In 2019, Medace decided to scale up and stand on its own two feet. On 1 January 2020, a new facility of over 2000 m2 was opened on the Brightlands Maastricht Health Campus. A tripling of the capacity with space for up to twenty companies and development projects.

Certification shortly after opening

And now, so soon after the opening, DEKRA has acknowledged the strict processes and procedures with the highest European quality standard in the field of medical devices. Danielle Curfs, CEO of Medace: ‘Scaling up such a flexible and modular service package is no easy task. The more parties and spaces, the more difficult it is to guarantee quality. I am really very proud of the team for achieving this success.

And of course also grateful that the parties responsible for funding Medace – the holding company of UM, LIOF, Maastricht UMC+, the Brightlands Maastricht Health Campus and Brightlands Chemelot Campus as well as the Province of Limburg – have given us this opportunity’.