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
Diagnostica
- 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