Innovative Medical Device

Put your quality to the test

Advances in medicine and public health are dependent on clinical research and approval. That’s why physicians rely on trials. They are central to determining the safety and effectiveness of medications, devices, diagnostic products and treatment regimes intended for human use.

TÜV SÜD’s Clinical Affairs specialists have the experience and the expertise to understand the needs of you and your customers regarding safe medical devices and patient safety. Aware that market pressures demand quick timelines, our scientists, professors and medical doctors work efficiently to assess your evaluation of clinical data based on clinical studies that meet market needs and regulatory requirements.

Your Innovative Medical Devices partner for:

• Assessment of your evaluation of clinical data based on clinical studies of medical devices with reference to safety and ability to perform. Among others, this includes class III medical products, implants and active implantable medical products.
• Consultation procedures for medical devices/drug combinations at the respective drug authorities within the scope of conformity assessment processes.
• Assessment of clinical test protocols.
• Conformity assessment of medical devices containing material of animal origin and/or human origin.
• Improve your process quality and transparency.