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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 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 a quality management system in accordance with EN ISO 13485:2003 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
Contact us- we look forward to hearing from you!