Quality Management System Certification
bonyf AG’s products are classified as Medical Devices and therefore falls under the guidelines of the European Medical Product Directive (93/42/EEC). This Directive requires a Quality Management System to be put in place which ensures the consumer that the goods have been manufactured and marketed to an internationally recognised standard of quality.
As the manufacturer of the product, bonyf AG, is solely responsible for implementing the Quality Management System for Medical Devices. bonyf AG chose to engage the services of an independent quality system certification body, DEKRA, to obtain and monitor on an ongoing basis the ISO Certificate of Conformity. The main advantage of opting for an independent certification body is the credibility that bonyf AG obtains by receiving an independent assessment.
Certificate for Quality Assurance
EN ISO 13485:2012 + AC:2012
Classification of the bonyf AG's products:
|BONYplus Denture Repairfix||Class IIa|
|BONYplus Fixobridge||Class IIa|
|BONYplus Cavifix||Class IIa|
|BONYplus Denture Relining Cushion||Class I|
|BONYplus 12 Hour Special Fixative Cream||Class I|
|BONYplus Express Tabs||Class I|
|BONYplus Denture toothbrush||Class I|
|NitrAdine® Denture Tabs||Class IIb|
|NitrAdine® Ortho & Junior||Class IIb|
|NitrAdine® SHINE Removable Aplliance Toothpaste||Class I|
|DiabetiXPro® Denture Fixative Cream||Class I|
|DiabetiXPro disinfecting Effervescent tablets||Class IIb|
|OlivaFix 24 hour Olive oil formulated||Class I|
|SterylBrush Tabs||Not a Medical Device|
As European law stands at present, if a product is classified as a Medical Devices then it is mandatory that the product displays a CE label. This indicates that the product can be sold freely in the open trade throughout the European Economic Area and that the manufacturer has given a declaration to the effect that he meets the fundamental (quality) requirements for medical devices under Directive 93/42/EEC.
This Directive distinguishes between various classes of Medical Devices, categorized by risk level and required effectiveness; those in Class I represent the lowest degree of risk, whereas those in Class IIb are higher.
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