Medical Device Processing

Do you need or want to process "C critical" medical devices? We certify your quality management system based on the EN ISO 13485 standard for medical device processing. This certificate shows that you process devices in a manner that enables safe and sanitary operations – as defined in the RKI/BfArM recommendation entitled "Hygienic requirements for the processing of medical devices."

Certifying your quality management system by TÜV Rheinland enables you to:

• Comply with the operator requirements specified in the Robert Koch Institute's recommendations, and Section 4 of the ordinance for medical device operators
• Document your processes transparently
• Lower your risk of liability through documented safety standards
• Identify and minimize weaknesses in your processes
• Benefit from our fast certification times and years of experience

We certify your quality management system based on the EN ISO 13485 standard for processing medical devices. Our experts examine your entire process, focusing on the following:

• Risk classification for all medical devices processed
• Suitability of procedures, equipment, and systems
• Labeling, traceability
• Quality assurance: organization, processes, interfaces, responsibilities, etc.
• Validation and routine checks
• Documentation of processes
• Staff training and professional development

1. Optional Preliminary Audit
Consultation and preliminary assessment, including site inspection and review of quality management documentation.

2. Initial Certification Audit: Phase 1
We audit your site to determine whether you are eligible for certification or analyze all the required information about the company. We review your quality management documentation for compliance with the EN ISO 13485 norm.

3. Initial Certification Audit: Phase 2
On-site, we review how the quality management system is applied in practice and evaluate how effective it is.

4. Certificate
If your company meets all the criteria, we issue a certificate confirming compliance and integrity of your quality management system.

To process "C critical" medical devices, hospitals or other businesses need to have a certified quality management system installed, based on the EN ISO 13485 standard for medical device processing. As Germany's first ZLG-accredited body, we offer the exclusive expertise and reliability needed to provide this service (the ZLG coordinates the use of medicinal products and devices in Germany).

Nosocomial infections in health care establishments are a recognized problem in industrialized countries. These infections can be caused by medical devices that have not been processed properly. A quality management system ensures that medical devices are processed so that they operate in a completely sanitary and safe fashion.

As a notified body for medical devices and a certification agency for the EN ISO 13485 standard, we have extensive experience evaluating quality management systems for medical devices. In addition, we are an accredited body authorized to issue certifications based on the hygiene requirements for processing medical devices outlined in the recommendations of the Robert Koch Institute (RKI) and the German Federal Institute for Drugs and Medical Products (BfArM).