Certified Quality - Safety for Surgery
The quality of our products and processes is 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 and it fulfills the requirements of the following standards:
DIN EN ISO 13485:2016 + AC:2017-07
EN ISO 13485:2016 + AC:2016
ISO 13485:2016
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 according
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), and active surgical devices (MD 1104) according annex.
CONFIRMATION LETTER
of the Notified Body DQS
Reference: 1000140215
Dated: 2023.10.13
This Confirmation Letter of the Notified Body DQS confirms that
RUDOLF Medical is in the Medical Device Regulation (2017/745)
certification process and fulfills the transitional provisions.
RUDOLF products continue to be compliant.
CERTIFICATE for the Quality Management System ISO 13485:2016
(MDSAP -
MEDICAL DEVICE SINGLE AUDIT PROGRAM)
The scope of this certificate and applicable countryspecific requirements are the development, manufacture,
service and sale of surgical instruments, equipment and devices as shown in the certificate and the annex.
AUS, CND, JPN, USA