Medical Devices, Pharmaceuticals, Life Sciences, IT & Health Tech

We are pan-European consultants who help companies bring innovative products to market in controlled environments.
Why MalsenGet in touch

Our Expertise

At Malsen, we have extensive experience of all stages of the product and company life-cycle; from the initial product conception, industrialisation, through to local and global market launch with our support all of the way. We enjoy complex technical and political challenges in controlled environments, where the best practices need to be deployed company wide.

News

Highlights 2021

Last year we experienced broad growth across our business with successful deliveries in many projects, winning new clients and adding resources in several disciplines.   Some highlights:   Ensured certification of a medical device class I software and built...

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Selected customers

Diagnostica

Diagnostica is a medical IT company that markets the product Spirare used by health care professionals to visualize and manage data gathered from several modalities. Malsen Medical created the technical file for compliance to MDD and associated QMS. Full compliance to...

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Pharmasens

Pharmasens, as Swiss based company, are developing a ground breaking insulin delivery platform. Malsen Medical is helping to drive the project is several areas including risk management, specification and requirement management, compliance planning, FDA submission...

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IVF-FIT

IVF fit are an IVD company who are developing a novel test method to improve the chances of successful in-vitro fertilisation. Malsen have been supporting the team to structure the organisation, working with QMS and project documents. We have also used our extensive...

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Arvato

Global IT specialist, Arvato Systems, support major companies through digital transformation. As a Blueprint Service Provider of the European Medicines Verification Organisation, they offer the 28 European member countries as well as the other non-EU members a tried...

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EpiGuard

EpiGuard is the medical device company responsible for the revolutionary EpiShuttle product. EpiShuttle is central to the safe transport of COVID-19 patients. Malsen Medical have been involved with EpiGuard for several years to set up their QMS, Design History File,...

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Vision statement

Our vision at Malsen is to be the partner of choice for companies operating within medical devices, in vitro diagnostics and pharmaceutical sectors. We develop long-term trusted relationships, and provide reliable solutions with lasting results to our clients. We thrive on seeing successful products brought to market, knowing that we contributed to our client’s success.

A person holding a tablet displaying an electrocardiogram