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Medical Device Services

Medical Device Services

Our Medical Device Services branch originated from personal pain. With regulatory requirements soaring and a new European MDR law, keeping even notified bodies on their toes, many of our portfolio companies had reached the limit of what they could shoulder on their own.

Every day we help companies navigate hard and uncertain regulatory terrain, often considered the number 1 business risk. Having a dedicated team with over 100 years of industry and clinical experience at arms length, fuels our customers’ long-term growth trajectory.

Compared to your ordinary clinical research organisation, our focus lies 100% on medical devices. LS medcap offers a complete range of services from pre- to post-market. Our pragmatic, no fuzz approach reduces coordination efforts, keeps bureaucracy at bay and lessens the risk of project delays.

We work with a quality management system certified in accordance to the international standard DIN EN ISO 9001:2015.

Small and mid-sized medical device companies in Europe with global ambitions are our customers.

Our services

In-depth clinical evaluation of commercial medical devices, applying industry and clinical expertise.

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Fuelling business growth through clever QM & RA strategy focused on EU and USA markets.

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Highly specific support for any medical device clinical investigation.

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One-stop-shop microbiological and sterility testing for medical devices.

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Medical Device Services