Orthopedic Medical Devices（英語）

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:

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