CERTIFIED QUALITY - SAFETY FOR SURGERY

The quality of our products and processes becomes objectively measurable due to the neutral evaluation through DQS Medizinprodukte GmbH in regularly performed audits.

CERTIFICATE for the Quality Management
DIN EN ISO 13485 : 2016 + AC : 2017-07
EN ISO 13485: 2016 + AC 2016
ISO 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)