Processing of medical products

To process certain medical products that are classi­fied as "C critica", hospitals are required to operate a certificated quality management system.

As Germany´s first and so far only accredited body (accredited by the ZLG, the Federal States Central Health Protection Agency for Drugs and Medical Products), we offer you this service and provide it competently and reliably.

The purpose of the regulations
Nosocomial infections that occur in health care establishments are a recog­nized problem in the industrialized countries. Medical products that are not processed properly are one reason why they occur. A quality management system is designed to ensure that the medical products processed function in an entirely hygienic and technically safe manner.

We are here to help you
As a "notified body" for medical products and a certification agency for quality management systems in accordance with DIN EN ISO 13485: 2003 , DIN EN ISO 13485:2001, DIN EN ISO 13488:2001 and DIN EN 46003:1999, we have exten­sive experience of evaluating quality management systems in the medical products area. Building on this experi­ence, we are the first accredited body to be authorized to issue, on the basis of the recommendations of the Robert Koch Institute (RKI) and the German Federal Institute for Drugs and Medical Products (BfArM), certifications in respect of hygiene requirements in processing medical products.

The certification process
In the course of certification the entire processing workflow is checked. We also undertake the following checks:

• A risk assessment of all the medical products to be processed
• A suitability assessment of the pro­cesses, plant and equipment used 
• Labeling/traceability
•  Quality assurance (organization, work­flows, interfaces, responsibilities, etc.)
• Validation and routine checks
• Documentation of processes
• Training, further training and continuing education of personnel

Benefits of certification at a glance

• Implementation of operators duties as required by the RKI recommendation and the German Medical Products Operator Ordinance (MPBetreibV, § 4)
• Transparent and legally secure work­flow documentation
• Recognition and minimizing of critical points
• Continuous process and structural improvements
• Cost savings
• A trustworthy certificate
• Minimizing of liability risks

Advertise with your quality and with our statement
Anyone can advertise, but when we have tested and confirmed for you the quality of your processing of medical products, you then have the opportunity to advertise with a statement made by an impartial third party by saying, for example, "Our Medical Products are Processed Properly  Says the TÜV Rheinland".

We will say so for you and your customers with your own TUVdotCOM mark and your own TUVdotCOM Web page. See for yourself, visit www.tuv.com and click on the heading TUVdotCOM-Service.

Contact us- we look forward to hearing from you!