Nanomaterials are found throughout the medical devices industry. Favoured for their enhanced mechanical, biological and chemical properties, they are used in devices including synthetic bone grafts, wound dressings and medical instruments. Manufacturers need to consider how the use of nanomaterials impacts the device design, risk, biocompatibility, toxicity, and the other chemical, physical and biological properties of device.
As a Notified Body, our team of experts have experience in material science and device design, particularly in orthopaedic and dental devices, active implantable devices and woundcare.
Understanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.
