OUR CORPORATE AND PRODUCT QUALITY MANAGEMENT SYSTEM
OUR PRODUCT QUALITY SYSTEM
Our UNI EN ISO 13485: 2012 certification ensures that all our medical devices meet all optimal parameters.
Accredia and Kiwa are the two accreditation bodies who periodically audit, review, and issue our certifications.
OUR CORPORATE QUALITY SYSTEM
Our UNI EN ISO 9001:2008 certification ensures that BIOSAFIN’s production cycle – from research to storage and distribution – meets all the optimal parameters for both the dentists who use the product and the patients as end users.
THE WINSIX® IMPLANT SYSTEM THIRD PARTY AND PRODUCT LIABILITY INSURANCE
WINSIX® implants have always been produced according to stringent quality standards. Every implant is checked one by one. Thanks to the accurate manufacturing process and quality features, all WINSIX® implants are covered by a third-party and product liability insurance.
Our company’s growth, attention to quality, and regulatory compliance are also expressed in the trademarks we have registered since 1995.
WINSIX® IMPLANT SYSTEM
The WINSIX® implant system complies with international and EU directives concerning medical devices and invasive devices. It has also obtained FDA clearance in the United States.
The CAB® CLIP-ABUTMENT-BAR SYSTEM
- Our CAB® device is covered by an international patent (PCT/EP2011/072448) for its technology and innovation.
- It has also been recognised by the United States Patent and Trademark Office.