Malsen Medical are attenting Arab Health in Dubai 2023

Who are we?

Malsen Medical is a multinational company with offices in Norway, France and Germany and network throughout Europe.


Our goal is to support companies with expert advice and execution on:

  • MD & IVD Project execution
  • Cybersecurity and software validation
  • Commercialization
  • QA/RA

Customer Excerpt

Customer Showcase

  • MD Project execution – “HAT Project”​
  • Cybersecurity and software validation – Serialization, EU FMD “France MVO”, “Arvato”​
  • Commercialization – “Cimon Medical”​
  • QA/RA – “Diagnostica”

(Minitech HAT) MDR Project Execution

 The Challenge​

  • Norwegian air ambulance needed a novel solution for active head warming​ to treat hypothermia, a condition commonly seen on rescue of outdoor patients.
  • No products fulfilling the requirements existed in the market

    The Malsen Solution​

    • Identification of potential manufacturing partners in the “active heated garment” space
    • MDR Project execution leadership
        • Full product development inc verification & validation and manufacturing qualification
        • Full RA/QA documentation/submission package
    • Commercialization support 
        • Pricing and Market access
        • Partnering model for distribution

    (Arvato) Cybersecurity & software validation

    Serialization, EU FMD – Provide a European database and connect 140.000 end to avoid counterfeit of medicines

    • Arvato, NMVS Blueprint provider
    • NomVec, NMVO Norway
    • AMVS, NMVO Austria
    • France Medicine Verification Organisation to 24.000 pharmacies to provide

    The Malsen Solution​

    • QMS and processes setup
    • System validation and Change control
    • Testing and release of software updates
    • Data Integrity focus
    • System Interoperability Testing
    • Audit

    (Cimon Medical) Commercialization

    Cimon Medical

    • Cimon Medical has completed the development of a novel Doppler Ultrasound Scanner
    • With the CE mark the road is now clear for the commercial phase
    • Further funding will be needed for the commercial phase from VC or strategics

    The Malsen Solution

    • Full development and validation of business case
        • Market access
        • Sales model
        • Country specific 
    • Creation of investor deck content specifically on the market potential
    • Reimbursement strategies for the main markets

    (Diagnostica) QA/RA


    • Several legacy products needed to be revisited to comply with new IVD/MDR directives

    The Malsen Solution

    • Full review of DHF/DMR files with gap analysis
    • Creation of new SOPs and systems needed for compliance
    • Internal trainings and introductions to new 
    • Mock audit 
    • Submission and new CE certification granted