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Malsen Medical is a consulting company based in Norway and France, with a Europe-wide network that has successful track records in bringing both medical and in-vitro diagnostic devices to the market. We have our core competence in leadership across all phases, with a strong focus on the quality, regulatory, IT and financial aspects of the value chain. We have a wide range of competent partners to allow us to drive every area of the development through to final production.
Over the years, we have developed a starter-kit for medical device, IVD, and pharma companies. This contains the basic SOP’s required, document control, classification/strategy, and a milestone-driven delivery plan.
For our more experienced customers, we deep-dive into validation (software & process), global registration, cybersecurity, etc. to bring the processes back under control. Through our ongoing projects across Europe, we promote and help define best practice. We, therefore, also know what is not required in every area. We steer projects to successful completion.
Here in Norway, we have helped several prominent companies bring their devices to market, and we are now expanding our resource base in Norway to support our growing customer base.