In November, auditors from mdc Medical Device Certification GmbH performed an ISO 13485 audit. The audit covered key areas like product development, the implementation of individual manufacturing steps in detail, over the maintenance of the machines and supervision of the clean room up to the training documents of individual workers. All standard-relevant processes were controlled. After intensive examination by external auditors, the ISO 13485 certification of Natural Dental Implants AG was renewed. During the audit, neither major nor minor deviations were found. The re-certification reflects the high-quality standards of the organization, and processes for the production of REPLICATE® Tooth devices.
At the beginning of December, the Implant Expo took place in Düsseldorf. We were of course there with our beautiful booth and have received dentists and many other interested parties. The Implant Expo took place in parallel to the 31st Annual Congress of the world’s second largest scientific implantology society DGI (German Society of Implantology) and attracted thousands of visitors to the exhibition halls in Düsseldorf.
The REPLICATE System received an award from the Clean Implant Foundation (CIF). The CIF was founded as a non-profit organization in 2016 to conduct regular independent analysis of the quality of dental implants using a defined protocol. Even if all implants are delivered sterile, it does not mean that there are no residues from the production on the surface. The CIF uses a scanning electron microscope to analyze the surface and looks for organic contaminants or inorganic residues from production. In 2014 and 2015, a good 140 different dental implants from almost 100 manufacturers were examined. Back then, the REPLICATE system was already listed as one of the cleanest implants, well ahead of most major screw-type implant manufacturers.
For 2017/2018, the CIF has now introduced the “Trusted Quality Mark 2017-2018” certificate. Manufacturers who are looking for very pure products can have their product inspected by the CIF. If it meets the high standards of the CIF, then the product is awarded. At the Implant Expo 2017, Dr. med. Dirk Duddeck, managing director of the Clean Implant Foundation CIF GmbH, awarded the certificate to Lea Ellermeier and Ruedger Rubbert, co-founders of NDI (see: http://www.cleanimplant.com/Home/)
[from left to right: Ingo Fritz, VP Sales, Lea Ellermeier, CEO, Rüdger Rubbert, CEO, Dr. Dirk Duddeck, CIF]
We are pleased to be one of the first companies to receive this award. The “Trusted Quality Mark 2017-2018” and ISO 13485 re-certification reflect the quality standards that go into making every REPLICATE Tooth.