Certfication
Kinevolution®: Choice of Certified Quality !
Kinevolution® has received marking as a class II Medical Device. Therefore, the therapeutic claims are certified and approved by European recognised entities. Its design and production satisfy more than 12 harmonised European standards with which its compliance has been tested by independent French laboratories with COFRAC certification.
Our commitment to your safety and that of your patients :
There are several types of CE marking.
Equipment can receive CE marking based on another guideline (for example, the machine guideline, the SEM guideline, by definition, that do not cover the obligations of Medical Devices). Others can be class I medical devices (auto-certification by the manufacturer). Our compliance with the guideline for Medical Devices 93/42/CEE of class II is certified and ensures that our equipment has followed strict rules for design and validation by laboratories and entities concerning the following:
- Essential requirements for medical devices
- Electrical safety for medical devices
- Mechanical safety for medical devices
- Protection against fire safety for medical devices
- Electromagnetic compatibility (EMC)
- Biocompatibility for medical devices
- Risk management for medical devices
- Logical development for medical devices
- Aptitude for use of medical devices
- Clinical and scientific studies
- Etc.
Our particular aspect: entirely certified organisation
Therapeutic and technological innovations are our driving force, but we have also decided to provide you with the most highly performing products and services. To do this, our study and production centres also have ISO 13485 version 2012 certification (certification of Quality management system for manufacturers of Medical Devices), a guarantee of quality and service which are provided to you. The directorate and all technical and business staff have made a commitment throughout the process of design, production and after sales service to satisfy you.
French Research, Design and Manufacturing
Designed and manufactured in France, our products comply with French and European standards for manufacturing and quality, as well as regulations relating to employment and security.
The parts are manufactured in France, near to the assembly firm, the centre for assembly which itself is near you, thus contributing to durable development.