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 EN ISO 13485:2012 + AC:2012
 


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.

The EN ISO 13485 Standard is specifically designed for medical device companies and is mandatory for most medical devices belonging to the classes 2a, 2b and 3 . This standard supplements ISO 9001 but has additional requirements for process control, design control, retention of records, accountability, traceability, customer satisfaction etc.

 

 

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.