Cardiovascular Medical Devices

TÜV SÜD is one of the world’s largest EU Notified Body for the extensive range of medical devices covered by EU directives and regulations. We are also a leading certification body for quality management systems, including systems applicable to medical device manufacturing.

TÜV SÜD testing labs technical experts test components, raw materials, prototype creations, and final medical devices adhere to the highest standards.

We offer a wide range of testing, certification, and auditing services to manufacturers of medical devices, including high risk implantable devices. This helps them manage risks and protect and promote the health and safety of patients.

Our global network of more than 1500 dedicated medical health and services professionals includes scientists and physicians recognised as authorities in their fields. This expertise includes high-risk cardiovascular devices and ranges from the technical to the clinical. We also have knowledge of specific fields such as tissue of animal and human origin, absorbable devices and medicinal substances.

Represented in over 1,000 locations worldwide, TÜV SÜD has an unsurpassed track record of meeting the expectations of our client companies. TÜV SÜD’s brand and our distinctive blue octagon mark are instantly recognised around the globe as symbols of quality and safety. They will increase customer confidence in your brand.

TÜV SÜD’s services for cardiovascular and other high risk medical devices include:  

• Technical Documentation Review – TÜV SÜD Notified Body reviews the technical documentation for the device according to the requirements applicable to high-risk devices. We then issue the required product certificate following the completion of a positive assessment. Our specialists who conduct these reviews have vast experience in specific cardiovascular devices.  
• Quality System Auditing – TÜV SÜD Notified Body performs a quality system audit consistent with regulatory requirements. Once we complete a positive assessment, we will issue a Quality Management System certificate. In addition, to help you achieve global market access in a wide variety of regions, we offer certification in accordance with the Medical Device Single Audit Program (MDSAP).  
• Testing Services – TÜV SÜD testing labs offers a wide range of testing services including biocompatibility, chemical characterisation, cybersecurity, MRI safety, sterilisation, and packaging.  
• Clinical Services – TÜV SÜD Clinical Centre of Excellence comprises clinicians trained in medical devices regulations and fully dedicated to clinical reviews. Our unrivalled in-house clinical expertise covers the areas of heart surgery, interventional cardiology, electrophysiology, neurovascular surgery and many others.
• Market Approvals and Certification – 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. We asses medical device manufacturers products for compliance and regulatory standards that vary from country to country.   

TÜV SÜD 's certification and testing services are independent of each other and do not impact one another. Our certification services are delivered by TÜV SÜD’s recogniszed Notified Body, while our testing services are conducted through TÜV SÜD Testing Labs.