Orthopedic Medical Devices

Your compliance partner as backbone for market access

Your compliance partner as backbone for market access

Next generation of safety and reliability

From joint reconstruction to entire spinal systems or to orthoses after injuries – orthopedic technology is an important area of the medical device industry. An area that is growing steadily due to an aging population, rising rates of obesity, orthopedic diseases, degeneration, and sports-related injuries. In addition to a rapidly growing market, the field of orthopedic and dental technology is accompanied by constant innovations. With 3D printing processes (additive manufacturing), new biomaterials and intelligent implants, ever-improving clinical orthopedic products are being developed to meet the most diverse needs of patients. Automation technology and robotics have become indispensable in the manufacture of these high-quality medical products.

This is why TÜV SÜD has identified the orthopedic and dental device sector as one of four main TÜV SÜD strategic focus areas, with the other sectors being:

Active medical implant

Cardiovascular medical devices

 Functional Safety, Cyber Security, Software & Artificial Intelligence

Active Medical Implant 

Cardiovascular Medical Devices 

Functional SafetyCyber SecuritySoftware & Artificial Intelligence

As new innovations emerge, the developmental process might be complex and is subject to increased regulation and responsibility. In a highly competitive environment largely driven by innovation, orthopedic and dental medical device manufacturers face numerous challenges. Some of these challenges include the high costs of innovation, the obligation to conduct pre-market clinical trials, and the stringent requirements of MDR and compliance with the Medical Device Single Audit Program (MDSAP).

 

Download Overview of additive manufacturing standards

HOW CAN WE HELP YOU

TÜV SÜD – as one of the world’s largest EU Notified Body – will support you on the road to certification and fast market access with:

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MDR Conformity Assessment Procedure

Medical Device Regulation
Quality management Clinical Services
medical device market approval Medical device testing
Expert training Transfer to tuv sud

We support you to help patients around the world with safe, effective and innovative orthopedic and dental medical devices! We enable progress as your single source service partner of choice for safety, security and sustainability solutions.

Our global network of more than 750 dedicated medical health and medical services professionals in more than 30 locations worldwide include noted scientists and physicians recognized as experts in both technical and clinical aspects of high-risk implantable devices.

These capabilities make TÜV SÜD a preferred single source for worldwide compliance with medical device regulations. In addition, we are a leading global management certification body for quality management systems. This unique combination of experience makes TÜV SÜD your ideal partner to achieve or maintain compliance with medical device requirements in the EU and major world markets.

Our TÜV SÜD experts are actively involved in standards development activities related to all types of medical devices and participate in key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on medical device standards and regulations. TÜV SÜD experts participate in and host webinars such as Digital Dialogs. For more information, you may follow us on TÜV SÜD MHS LinkedIn Showcase Page.

Furthermore, the TÜV SÜD brand and our distinctive blue octagon mark are instantly recognized around the globe as symbols of quality and safety, and will thus increase customer confidence in your brand.

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EXPLORE

Additive Manufacturing for Orthopedic Implants
Webinar

Additive Manufacturing Custom Made Orthopaedic Devices

Join the discussion of differences in MDR regulatory pathway for custom made and patient matched devices.

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Addictive Manufacturing for Orthopedic
Webinar

Additive Manufacturing of Orthopedic Medical Implants

Learn about requirement and opportunities additive manufacturing of orthopedic medical implants

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Additive manufacturing medical regulations
White paper
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