Changes to materials, components or processes of medical devices must be reliably validated in order to maintain product quality and regulatory conformity. We support you with a specialized test portfolio for the laboratory-based validation of such changes - efficiently, in compliance with standards and in a practical manner.

Processing / Repeated Processing of Products:

• Microbiological efficiency control of automated or manual cleaning and disinfection
• Microbiological efficiency control of the sterilization process

Packaging Systems:

• Packaging validation/proof of maintenance of the sterility assurance level: integrity of the sterile barrier system (visual, microbial barrier testing, seal integrity) as well as accelerated ageing and mechanical treatment
• material suitability
• Toxic properties

Biological Safety:

• Biological testing (e.g. cytotoxicity, blood compatibility and other tests) and chemical characterization in accordance with ISO 10993, also as comparative tests to ensure patient safety
• Biological evaluation including toxicological risk assessment according to ISO 10993-1,-17

Your Advantages:

• Targeted testing services for design, material or process
• Accredited laboratories in accordance with international standards (e.g. ISO 17025)
• Fast processing of tests and reliable results
• Comprehensive documentation to support your internal validation

Our test data provides the basis for safe and traceable changes to your medical device - feel free to contact us.