Team &
LOcations
We are a consulting company that was founded in 2018. Malsen Medical found there was a growing need to coordinate multiple stakeholders and bring together talented people from across Europe to solve complex problems. We work on pan-European projects, as well as local projects with a global focus.
Our consultants have deep experience in their fields and Malsen continue to develop best practice solutions for our clients. Using our tools, we streamline processes and work with our clients to move through change and raise the organisation.
Our clients range from large multinationals, through to small one person startups. All of which need to find efficient ways to comply to the latest regulations for medical and pharmaceutical products. Often, we are brought in during major challenges, and we have a long track record of success in bringing all organisation forwards.
Bjørn Olsen
CEO and founder
PhD in Biomechanics with leadership roles from Roche (Switzerland) and other global companies to successfully develop a range of new devices from concept to launch and post market. Bjorn has managed several FDA remediation projects to help companies turn around quality issues.
Bjorn builds quality- and business systems and help companies develop the right product for their market. He enjoys to help see the trees in the forest and navigate in challenging waters.
Gergana Georgieva
Quality
Pharmacist with several years of experience in pharmaceuticals, medical devices and food supplements. Gergana has worked in the areas of Regulatory Affairs, Quality and Pharmacovigilance.
Lately she is focused on Quality Management Systems, Risk Management and Project Management.
Gergana enjoys problem solving, getting things in order and is focused on the details.
Henrik Schmidt, MBA
Business Development
20+ Years in Commercial roles with leading medical device companies in global and local roles in Denmark, Germany, Switzerland and USA.
Focus on deal creation, market access and funding.
Henrik enjoys linking up people across the globe with common interests to bring business forwards. He see opportunities where others may not
Asma Lammari
IT and software validation
Started out in production controls with global pharmaceutical companies and has worked in global IT for the last 10+ years. Set up and managed the batch recall system in France, and has been central in setting up and validating the European serialization for Pharm (FMD).
Asma enjoys working on complex challenges and working with many stakeholders.
Alex Lazell
Engineering
Specialist in product development, industrialisation, manufacturing & tech strategy. Alex has over 15 years experience and has led the development of multiple devices from idea through to market, including the development of manufacturing processes and facilities.
Alex has also worked across several start-up companies and enjoys being both hands-on as well as creating and developing short and long-term technology strategies.
Allen Pearson
Innovation
Specialist in Drug delivery device innovation and medical device development. Allen has had 30 years experience in Device development running his own design consultancy in Cambridge, UK. He has over 30 patents to his name and loves the thrill of a technical challenge. He is very much a hands-on engineer, always striving towards perfection.
Vision
Locations
We are an employeed owned company with offices and people across Europe and Africa. Below are our subsidiary offices, we have consultants in several more locations.
France
Our France office in near the heart of Paris. Here we focus mainly on IT and pharmaceutical systems.
Germany
In Germany we are located close to Heidelberg. Business development and commercialization is our focus out of the German office.
Norway
In Norway we are in the center of Oslo. Here we work with lots of startups helping with full scale project execution, quality and regulatory.
United Kingdom
Situated near Cambridge, our British office works with innovation, prototyping and product development.
Kenya
Malsen is located just north of Mombasa on the Kenyan coast. Here we are building up compentences in quality support and operations.