InSciTe is extremely proud to announce that the biomedical accelerator support and service matrix has once again been EN ISO 13485:2016 accredited. This accreditation hallmarks the highest European quality standard in medical devices.
The support and service matrix is used to accelerate medical device and cell therapy projects and companies on their journey in bringing innovations to the patient. The philosophy of the model is that by sharing (knowledge, infrastructure or personnel) costs can be reduced and developments accelerated. The matrix model that is now ISO certified contains elements for equipment, infrastructure and personnel, all under an overarching quality management system. By assessing the stage of development a project or company is in, we can provide a customized service menu per client. Doing so, guarantees the best possible support, whilst keeping costs as low as possible.
“This ISO certification is the reassurance that the service we provide meets the highest European quality and regulatory standards in medical device development.”
Within the shared facilities of InSciTe Biomedical, seven public-private projects and four companies are served according to the matrix model. This open innovation way of working in product development is unknown and makes the ISO accreditation extra unique. This certication is the assurance that we have carefully defined procedures in place to oversee all our lab activities such as research, design and development, risk management, monitoring and good document practice. With this in place, we can support and accelerate the road from 'Patent to Patient' of our clients in a safe and responsible manner.
“We are very happy to have received this crucial quality recognition for our way of working. The next step will be to further professionalize this model, so we can accommodate even more projects and companies on their way to the patient.”