Next generation of safety and reliability
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).
How can we help?
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.
Why choose TÜV SÜD
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.
Our services at a glance
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.
- MDR trainings and workshops – TÜV SÜD conducts MDR training and workshops covering general MDR requirements and compliance.
- 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.
Your benefits at a glance
- Recognised medical device expertise - TÜV SÜD is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs Department and an in-house Clinical Centre of Excellence, TÜV SÜD is recognised by global regulatory authorities for its extensive experience with all types of medical devices.
- Predictability – TÜV SÜD understands how predictability is key for the successful development and placement of a medical device on the market. That is why we offer clear timelines that can be tailored to the specific project needs and employ project managers dedicated to guarantee timelines are successfully met.
- Active involvement in standards development and implementation - TÜV SÜD technical professionals 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.
- Single source solution - TÜV SÜD offers a full range of review and testing services for high-risk medical devices as required by regulators in the EU, the U.S. and other major medical markets around the world.
- Expert partnership - TÜV SÜD is a trusted partner to companies ranging from global manufacturers to regional and local start-up companies.
1: Global Information, Inc
