Engineering
Malsen Medical run full-scale development projects for medical devices from concept to global launch.
Engineering Services at Malsen Medical
Develop Your Medical Devices with Our Engineering Insight
At Malsen Medical, we leverage extensive experience and a sophisticated approach to transform your innovative ideas into successful medical products. Explore our comprehensive engineering services designed to guide every phase of your medical device development.
Concept Evaluation
User and Market-Focused Approach: At the very start, our team focuses on understanding the needs of users and the market. We ensure your product concept is robust, with a solid foundation for future success. We integrate market insights and regulatory considerations early to streamline the path from concept to market.
Product Development
Experienced Execution Model: Our product development strategy is grounded in industry best practices and is driven by a seasoned team of engineers and technical regulatory experts. We commit to turning your concept into a viable product with precision and efficiency. Our approach is tailored to meet the specific demands and challenges of the medical device sector.
Industrialisation
Manufacturing and Testing Expertise: Transitioning from development to production is seamless with Malsen Medical. Our industrialisation process benefits from our extensive experience and a global network of production partners. We ensure that every product we launch is not only compliant with the highest standards but also robust and market-ready.
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Success stories
HAT
The HAT is based on an idea by the Norwegian Air Ambulance Foundation (SNLA). Their paramedics and rescuers were lacking a device that would immediately start and activate heat treatment, whilst leaving them room for treating the patient. The development is currently coordinated with SNLA and Minitech AS, a Norwegian leader in medical device heating systems.
We are very proud to have supported the Norwegian Air Ambulance and Minitech AS with the engineering and regulatory submittal for this project through all stages of development and MDR submission in just 2 years.
EpiGuard
EpiGuard. EpiShuttle is a medical isolation and transportation system designed for optimal safety and numerous treatment options during patient loading and transport. The unit is a single-patient isolator made of solvent-resistant materials. EpiShuttle can be carried and is compatible with leading ambulance-stretcher undercarriage EMS systems.
Malsen Medical have been Involved with EpiGuard for several years to set up their production, regulatory strategy, QMS and technical documentation.