Collaborative Requirement Management

Malsen Medical has added collaborative requirement management to our toolbox. Managing requirements, specifications, associated test cases and results is at the very core of controlled development. The image below shows an illustrative example of requirement...

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...

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...

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...

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...