In accordance with the MPBetreibV, this must be performed exclusively by qualified specialists who are not subject to instructions.
MPBetreibV, Section 8(4): The operator may only commission persons or companies to perform reprocessing and validation who possess the necessary expertise and meet the specific requirements under Section 5:
“…The validation and performance assessment of the reprocessing process must be carried out on behalf of the operator by qualified specialists who meet the requirements under § 5, paragraph 1, regarding the validation and performance assessment of such processes.”
What does this mean for operators?
- Validation is a legally binding requirement.
- It may only be performed by specialists who are demonstrably independent and qualified.
- The testing facility must be accredited and technically certified.
- Results must be documented in a manner that allows for auditing.
- Validation is not part of the manufacturer’s services.
Why Normec Hybeta is the legally compliant testing facility
- Accredited according to DIN EN ISO 17025
- Professionally independent and impartial
- Nationwide-recognized validation reports
- Documented qualifications of all inspectors
- Standards-compliant measurement and testing methods
- Complete validation documentation for inspections and audits
- Exempt from sales tax for healthcare facilities (Section 4 No. 14e of the German Sales Tax Act (UStG))
Commission your validation with us early on—ideally during the planning phase:
The prerequisites for subsequent legally compliant validation are established as early as the planning and procurement phases for new reprocessing equipment. Early involvement reduces the need for subsequent adjustments and provides clarity regarding technology, space, and processes
We provide comprehensive support
Building hygiene planning and independent validation are interlinked and create a solid foundation for audits—from planning through to robust documentation.
Ready for commissioning, inspections, and audits.
Your partner for quality, safety, and compliance
The life sciences sector requires specialized knowledge and reliable support. With our comprehensive expertise, we help companies comply with laws and regulations, ensure quality, and continue to innovate with confidence.
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