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BRUSSELS, Belgium: Neoss Group is proud to announce that it has received EU Medical Device Regulation (MDR) certification for its implants and abutments. This milestone adds to the 2022 MDR certification of Neoss’s quality management system (QMS) and Class I reusable instruments and signifies that the company’s QMS and implants and abutments meet the highest standards for medical devices.
“MDR is one of the most thorough medical device regulations in the world. It ensures that medical devices meet the highest standards. The certification shows that we are at the forefront of implant solutions and that we provide best-in-class quality and care to our customers and their patients,” commented Dr Robert Gottlander, president and CEO of Neoss Group.
The certification demonstrates that Neoss Group is fully committed to ensuring that its products exceed the expectations of its customers and their patients. The company is one of the first in the dental device field to achieve MDR certification for its products.
“The MDR certification gives Neoss the freedom to continue innovating intelligent solutions that benefit our customers and their patients. The MDR certification also shows that Neoss products are backed by leading clinical evidence and ensures that the products are continuously monitored in post-market studies,” said Fredrik Engman, chief technology officer and co-founder of Neoss Group.
The MDR, Regulation (EU) 2017/745, replaces Council Directive (EEC) 93/42, the former European Medical Device Directive, and brings EU legislation into line with technical advances, changes in medical science and progress in law-making. It creates a robust, transparent and sustainable regulatory framework, improving clinical safety and creating fair market access for manufacturers and healthcare professionals. The new regulation contains a series of important improvements, including the establishment of a comprehensive and accessible EU database on medical devices with a device traceability system based on a unique device identifier.
Preservazione alveolare con biomateriali di nuova generazione: risultati clinici ed istologici con follow-up a 2 anni