General Medical Device Services

Reusable medical devices

Safe reusable medical devices

We can help you design validation studies of your cleaning, disinfection, and sterilisation procedures that ensure the safety of your reusable medical devices and their compliance with relevant guidelines such as AAMI TIR12 and ISO 17665.

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ready-set-go safe to market

Ready-set-go safe to market

We provide you with everything you need to plan, test, and document compliance with ISO 10993-1. This is a crucial step toward securing a CE Mark certificate and getting your medical device to market in the EU and beyond.

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PRRC

Regulatorisk compliance service (PRRC)

Producerer du medicinsk udstyr? Har du færre end 50 ansatte eller en årlig omsætning under 75 mio. kroner? Så må du outsource dit PRRC ansvar i henhold til den nye MDR-lovgivning. Vi har ekspertisen til at varetage opgaven for jer.

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Timely Materials Screening

Timely materials screening

We can help you select and evaluate your medical devices construction materials for suitability and compliance readiness with regulatory requirements.

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Change Management

Manage change and stay safe

We can help you evaluate the impact of design and manufacturing changes on your compliance with ISO 13485 and 14971 regulatory safety requirements.

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Surface characterisation

Surface characterisation

Our analytical expertise helps get your medical devices through the physico-chemical, morphological, and topographical (PMT) characterisation process and ensure compliance with ISO 10993-19.

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