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...
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...
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...
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...
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,...
