TÜV SÜD is the world’s largest EU Notified Body for all types of medical devices covered under EU directives and regulations. We are also a leading global management certification body for quality management systems, including management systems applicable to the manufacture of medical devices. This unique combination of experience makes TÜV SÜD ideally suited to address the needs of medical device manufacturers seeking to achieve or maintain compliance with medical device requirements in the EU and major world markets.
TÜV SÜD bases its success in this field on the vast technical, clinical and regulatory expertise of the staff. Our experts are dedicated to high risk implantable devices, with expertise ranging from the technical to the clinical aspects and in specific fields covering patient specific implants, custom made devices, bioabsorbable materials, robotic surgical procedures and others.
As predictability is paramount for our customers, our experts are supported by a team of project managers providing assistance and support on all activities covering conformity assessment, ensuring resources are used efficiently and project timelines are scrupulously met.
TÜV SÜD offers a complete range of testing, certification and auditing services to manufacturers of medical devices, including high risk implantable devices, helping them to manage risks, protect and promote the health and safety of patients. Our global network of more than 600 dedicated medical health and services professionals include noted scientists and physicians recognised as authorities in their respective fields. These capabilities make TÜV SÜD the preferred single source for worldwide compliance with medical device regulations. Furthermore, the TÜV SÜD brand and our distinctive blue octagon mark are instantly recognised around the globe as symbols of quality and safety, and will increase customer confidence in your brand.
TÜV SÜD’s services for orthopedic and other high risk medical devices include:
- Technical documentation review – TÜV SÜD reviews the technical documentation for the device according to the requirements applicable to high risk devices, and issues the required product certificate following the completion of a positive assessment. The reviews are conducted by specialists with vast experience in the specific orthopedic devices.
- Quality system auditing – TÜV SÜD performs a quality system audit consistent with regulatory requirements, and can issue a Quality Management System certificate following the completion of a positive assessment.
- Testing services – TÜV SÜD provides compliance testing for high risk implantable medical devices in accordance with relevant regulations and standards. Assessments are based on witness testing conducted on the applicant’s premises.
- Pre-certification services – TÜV SÜD conducts modular and early stage Technical Documentation (TD) assessments and MDR Pilot projects to ensure readiness of procedures, availability of data and highlight potential deficiencies in QMS. Workshops covering general MDR Requirements training can also be arranged.
- Clinical services – TÜV SÜD Clinical Centre of Excellence comprises a number of clinicians trained on medical devices regulations and fully dedicated to clinical reviews. The in-house clinical resources cover the various orthopedic specializations and add value to the devices undergoing such an independent scrutiny of the clinical evaluation reports. The direct access to the clinical reviewers allows TÜV SÜD to offer high quality and fast clinical reviews, that can be tailored to the specific product or customer needs.
- Market approvals and certification – The regulatory requirements are often complex and vary between regions. TÜV SÜD has in-depth knowledge and experience of the key medical device markets around the globe to help you navigate the regulatory requirements and obtain the necessary approvals for your medical devices.