HARROGATE, England: Neoss Group has recently announced that it has obtained certification under Regulation (EU) 2017/745 (Medical Device Regulation—MDR) from its notified body, BSI Group Netherlands, for its NeoGen PTFE non-resorbable membranes. This certification completes the MDR certification for all Neoss products and solutions and adds to previous certifications of Neoss’s quality management system, implants, abutments and instruments. This means that Neoss Group’s quality management system and all its products and solutions comply with the requirements of the EU MDR legislation.
“We are pleased that Neoss has successfully navigated and achieved MDR certification with BSI for the full range of non-resorbable dental membranes. The review and certification processes are robust and require a high level of collaboration with manufacturers to ensure compliance with the new regulation. Our technical team at BSI has significant expertise in dental products,” stated Dr Chris Wylie, global head of orthopaedic and dental at BSI. “The completion of all initial certifications with Neoss reflects our progress in transitioning to MDR and supports the shared goal of continued patient access to safe and effective products under the new EU regulations,” he added.
“The NeoGen PTFE membrane, developed by Neoss, is an important product for both patients and clinicians. With proven effectiveness for guided bone regeneration, the membrane enables restored chewing function, speech and aesthetics for implant patients. MDR certification demonstrates that the NeoGen membrane is supported by rigorous testing, clinical evidence and ongoing studies, ensuring patients receive the best possible care and that dental professionals can rely on these products. This regulatory milestone once again shows that Neoss Group is at the forefront and that our products and solutions meet the highest standards of quality and safety, all for the benefit of our customers and their patients,” commented Fredrik Engman, chief technology officer and co-founder of Neoss. Engman developed the NeoGen PTFE membrane.
Topics:
Tags:
ZURICH, Switzerland: Neoss, a leading innovator in dental implant solutions and digital workflows, has launched NeoGenix Extraction Allograft, extending its...
COLOGNE, Germany: Neoss Group has announced that Sandra von Schmudde will assume responsibility for the Belgian, Czech, Dutch, French, Hungarian, ...
WALTHAM, Mass., US: Neoss Group has recently announced the appointment of John Chopack as managing director of Neoss USA. Chopack joined Neoss Group in ...
BRUSSELS, Belgium: Neoss Group is proud to announce that it has received EU Medical Device Regulation (MDR) certification for its implants and abutments. ...
BERLIN, Germany: Neoss Group, a leading innovator in dental implant solutions, has launched the fast and easy-to-use wireless intra-oral scanner NeoScan ...
Dr. Domenico Patarino, Dr. Paolo Spina
To post a reply please login or register