The orthopedic devices sector is a dynamic field of the medical device industry. Devices available can be categorized, for example, as joint reconstruction, orthobiologics, trauma fixation devices, spinal devices, accessories, braces and arthroscopic devices.
The industry is constantly innovating, adding new products to meet varying needs. 3D-printed implants and instruments, new biomaterials, computer-assisted surgical procedures and smart implants are only few examples of innovative products that improve clinical outcomes. At the same time, new automation technologies and robotics are increasingly deployed in the manufacturing process, predictably delivering high quality devices for the growing market. Consequently, the global orthopedics industry is expected to reach an estimated USD 62.6 billion by 2022 and is forecasted to grow at a CAGR of 5.5% from 2017 to 20221. An aging population, rising rates of obesity, orthopedic diseases, degeneration and sports related injuries are more reasons leading to the increase.
As new innovations emerge, the developmental process can be complex and will be subjected to increased regulation and responsibility. In a highly competitive environment largely driven by innovation, orthopedic medical device manufacturers will face numerous challenges. Some of these challenges include high cost of innovation, obligation to conduct pre-market clinical investigations, stringent requirements of MDR and compliance to the Medical Device Single Audit Program (MDSAP).
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:
How to ensure a smooth transition to MDR certification.
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