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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 the services competently and reliably.
The purpose of the regulations
Nosocomial infections that occur in health care establishments are recognized problem in industrialized countries possibly due to not properly processed medical products. A quality management system is designed to ensure that the medical products are processed in 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), the German Federal Institute for Drugs and Medical Products (BfArM) for 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 provide the following lists:
- 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
