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Verification / Validation & Testing - reliable test data for safe Medical Devices
The safety, efficacy and regulatory compliance of medical devices are based on reliable test results. We offer you comprehensive laboratory services for the verification and validation of your products, materials and processes - from development to market surveillance.
Our Core Services:
Validation / Verification:
- Product cleanliness incl. chemical residue analysis and (micro-)biological and particle testing (DIN/TS 5343, ISO 19227)
- Sterilization processes (microbiological performance qualification, ISO 14937)
- Packaging systems (proof of the integrity of the sterile barrier system (visual, microbial barrier testing, seal integrity) as well as accelerated ageing and mechanical treatment, ISO 11607)
- Reprocessing / repeated reprocessing (ISO 17664-1/2, AAMI TIR12, ANSI AAMI ST98)
- Biological safety in accordance with ISO 10993, considering the whole life-cycle of a medical device, including biological evaluation (BER, ISO 10993-1) and toxicological risk assessment (TRA, ISO 10993-17)
- Chemical characterization to confirm material identity and cleanliness
- Stability and storage studies to verify shelf life
- Comparative tests or modification of products, materials and processes
Testing:
- Microbiological testing (e.g. bioburden, endotoxins, sterility, environmental monitoring)
- Particle testing
- Chemical analyses (e.g. extractables/leachables, cleaning residues, TOC)
- Biological testing (e.g. cytotoxicity, blood compatibility, etc.)
Your Advantages:
- Accredited laboratories with many years of experience in the field of medical devices
- Standardized and customer-specific test designs
- Fast processing times and reliable result reports
- High regulatory relevance of the results for MDR, FDA & Co.
Whether new development, process optimization, modification of existing products or new normative requirements - we deliver the tests you need for safe and compliant implementation.
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Ready to take your medical devices to the next level? Contact us today to learn how our comprehensive MedTech solutions can support your needs.
