CERTIFICATE for the Quality ManagementDIN EN ISO 13485 : 2016 + AC : 2017-07EN ISO 13485: 2016 + AC 2016ISO 13485: 2016
With this certificate RUDOLF Medical GmbH + Co. KG proves that it has implemented and applies the Quality Management System in compliance with the EN ISO 13485 Standard.
Scope:The development, manufacture, service and sale of surgical instruments, equipment and medical devices as listed in the certificate.
EC CERTIFICATE for Full Quality Assurance System - Annex II excluding Section 4 of Council Directive 93/42/EEC Concerning Medical Devices
This certificate refers to non-active instruments (MD 0106), non-active orthopaedic implants (MD 0202), non-active functional implants (MD 0203) and active surgical devices (MD 1104) according annex.
CERTIFICATE for the Quality Management System ISO 13485:2016 (MDSAP Audit Model Edition 2)
The scope of this certificate and applicable country-specific requirements is the development, manufac-ture, service and sale of surgical instruments, equip-ment and devices as shown in the certificate and the annex.-AUS (a), CND, JPN, USA (a,b,c,d)