A controlled and certified quality
Each of our medical device is submitted to a declaration of conformity based on :
• An evaluation procedure of conformity to Annex II.3 to the 93/42/CEE Directive related to medical devices for class IIb and IIa, carried out by an independant notified Agency (appointed to the obtention of the CE Certificate of our products),
• An evaluation procedure of conformity to Annex VII to the 93/42/CEE for Class 1 products carried out by Generic Implants (auto-certification),
• An evaluation procedure of conformity for its quality management system to the ISO 13485 : 2016 international norm, carried out by an independant notified Agency (appointed to the obtention of the Company authorization letter of conformity for conception, manufacturing of implantable and non-implantable non-active dental devices, prosthetical surface and ancillary for dental surgery).
All documents and certifications are available here below :
All Like Implants products are designed in France in accordance with severe specifications. Strictly controlled at each manufacturing stage, the products are srupulously traced all along their life, from the manufacturing start to the finished product delivered to the client. The device identification appears clearly, as well, on the implantation passport delivered to the patient by the practitioner.
Following informations assure the traceability :
• Utilized material and components,
• Various assembled parts,
• Manufacturing stages,
• Registration and controls ,
• Possible modifications.
For each piece, sub-contractor material certificates of conformity are registered in the batch file.