Definition
Medical devices are beneficial to human health and are primarily used for the diagnosis, prevention, monitoring and treatment of diseases. This includes various practical aids, diagnostics, as well as software components and many others. Pharmaceuticals are among the exceptions.
Speciality
The strict legal requirements of medical devices ensure their safety and effectiveness. Manufactures must comply with the EU medical devices regulation, which requires comprehensive testing, clinical evaluations and traceability. Additionally, conformity assessments and CE markings are mandatory to market the products in Europe.
Support
We provide expert consulting in all phases of the development and approval of medical devices. Our services include support with regulatory requirements, risk management, conformity assessment and clinical studies. We also assist you in preparing the necessary technical documentation to ensure the efficient approval of your products.