QUALITY & SAFETY

The Biotech Dental Group is committed on a daily basis to highly respect the medical quality and safety standards, production standards, quality of life at work standards, and so on. Thanks to concrete measures, Biotech Dental has been recognised by the accreditation of numerous standards and certifications.

Quality is the result of everyone’s constant involvement and actions in each of its daily gestures.

Our first duty is to serve dentists, health care workers, patients, and anyone who uses our products and services. We must show constant concern in everything we do to satisfy our customers.

EN ISO 13485:2016 CERTIFICATION

Biotech Dental is certified to EN ISO 13485:2016 by the notified body GMED (N°0459) for its medical device quality management system. This mark is the guarantee that the products marketed by Biotech Dental meet the European standards of manufacturing, traceability, safety, labelling and packaging. Carried out in the Arve Valley (Rhône-Alpes), the manufacturing process of the implantology products is ensured by specialists in the machining of dental implants.

FDA CERTIFICATION

The Food and Drug Administration (FDA: “The U.S. Food and Drug Administration (FDA)” is an agency with a mandate to authorise the marketing of drugs in the United States. With FDA approval, the Kontact™ implant system and Smilers® aligners are now available on the U.S. market. This validation by the FDA is a proof that our products meet the requirements of this benchmark organisation in the world of health: safety and efficiency.

CLEAN IMPLANT CERTIFICATION

The independent CleanImplant Foundation is a non-profit organisation that regularly coordinates quality assessment studies of dental implants and awards the “Trusted Quality Seal” to particularly clean implant lines. The Foundation’s Scientific Advisory Board has awarded the “Trusted Quality” label to the Kontact™ S implant. This internationally recognised award confirms the high level of design of our implants as well as our production facilities. At Biotech Dental, we will never compromise on quality because we are committed to providing the best products to our customers and patients.

DATA SECURITY

Secure 4 All is a sister company in the Upperside Group, providing hosting and security for the patient data of the Biotech Dental Group and all its entities. Working daily with excellence and ambition, Secure 4 All has been awarded ISO 27001 and HDS* (Health Data Hosting) certifications by Bureau Veritas, extending the RGPD compliance already achieved.

For Biotech Dental and its customers, these certifications have many benefits. They provide an answer to the challenges and problems of cybersecurity by guaranteeing a high level of security for their patient’s data. This is a truly crucial issue for all practitioners.