Malsen Medical
Malsen Medical is a consulting company founded in 2018, specializing in medical device, in vitro diagnostics, healthcare, and pharmaceutical regulatory and quality system consulting. They coordinate multiple stakeholders across Europe and globally, providing expertise in bringing innovative products to market, ensuring regulatory compliance, and developing best practice solutions. Their services include quality & regulatory affairs, business development, engineering, pharmaceutical systems, and project management. They serve clients ranging from startups to large multinationals, supporting market entry, product development, and compliance.
Industries
Nr. of Employees
small (1-50)
Malsen Medical
Products
Neptune (QMS / documentation management tool)
A documentation and QMS-focused software tool intended to streamline regulated project and quality documentation management and integrate with existing tools.
Neptune (QMS / documentation management tool)
A documentation and QMS-focused software tool intended to streamline regulated project and quality documentation management and integrate with existing tools.
Services
Regulatory strategy, QMS design and remediation, operative QA roles, technical file compilation and regulatory interactions for device, IVD and pharmaceutical clients.
End-to-end engineering from concept evaluation, product development and human factors to industrialisation and manufacturing transfer.
Software compliance, testing and validation services for pharmaceutical and healthcare IT systems including serialization, GAMP5 qualification and cybersecurity/GDPR support.
Market analysis, reimbursement/tender strategy, partner introductions, pitch/funding support and market-entry planning.
Planning, coordination and execution of multidisciplinary regulated product development projects.
Regulatory strategy, QMS design and remediation, operative QA roles, technical file compilation and regulatory interactions for device, IVD and pharmaceutical clients.
End-to-end engineering from concept evaluation, product development and human factors to industrialisation and manufacturing transfer.
Software compliance, testing and validation services for pharmaceutical and healthcare IT systems including serialization, GAMP5 qualification and cybersecurity/GDPR support.
Market analysis, reimbursement/tender strategy, partner introductions, pitch/funding support and market-entry planning.
Planning, coordination and execution of multidisciplinary regulated product development projects.
Expertise Areas
- Regulatory compliance for medical devices and IVDs
- Quality management systems (ISO 13485)
- Software validation and compliance (IEC 62304, GAMP5)
- Product development and human factors engineering
Key Technologies
- ISO 13485 QMS implementation
- IEC 62304 software lifecycle compliance
- GAMP5 system validation
- ISO 14971 risk management
News & Updates
Market introduction Germany
Worked with a leading UK company to drive a successful market entry into the German market.
Business development
Introduced company in Korea to key leaders in Europe / USA to build business partnership.
Diagnostica
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 IEC 62304 in context of MDR with a certified ISO 13485 QMS will help ensure continued business stability and growth.
Pharmasens
Swiss based company developing a groundbreaking insulin delivery platform. Malsen Medical is helping to drive the project in several areas including risk management, specification and requirement management, compliance planning, FDA submission preparation, labelling, verification testing, QMS and other areas. The device has now been submitted and passed FDA validation.
EPIGuard
EpiShuttle is a medical isolation and transportation system designed for optimal safety and treatment options during patient loading and transport. Malsen Medical has been involved in setting up production, regulatory strategy, QMS, and technical documentation.
HAT
Based on an idea by the Norwegian Air Ambulance Foundation, the HAT device supports immediate heat treatment activation for paramedics. Malsen Medical supported the development and MDR submission in 2 years.
Market introduction Germany
Worked with a leading UK company to drive a successful market entry into the German market.
Business development
Introduced company in Korea to key leaders in Europe / USA to build business partnership.
Diagnostica
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 IEC 62304 in context of MDR with a certified ISO 13485 QMS will help ensure continued business stability and growth.
Pharmasens
Swiss based company developing a groundbreaking insulin delivery platform. Malsen Medical is helping to drive the project in several areas including risk management, specification and requirement management, compliance planning, FDA submission preparation, labelling, verification testing, QMS and other areas. The device has now been submitted and passed FDA validation.
EPIGuard
EpiShuttle is a medical isolation and transportation system designed for optimal safety and treatment options during patient loading and transport. Malsen Medical has been involved in setting up production, regulatory strategy, QMS, and technical documentation.
HAT
Based on an idea by the Norwegian Air Ambulance Foundation, the HAT device supports immediate heat treatment activation for paramedics. Malsen Medical supported the development and MDR submission in 2 years.