Medtech
Product development with human health and technical precision in balance
Get help with the development of your medical device
You can come to us with an idea for a completely new medical device or an existing one that you want to further develop. Our engineers can help you with everything from pre-study to putting it into production. You choose for yourself whether you want help with a step or the entire product development. Regardless, we ensure that all documentation complies with regulatory requirements.
It's worth hiring us. Three times over.
You can trust us no matter what type of medical device or solution you want to develop or where you are in the process. It's primarily three specific values you can count on when it comes to product development in Medtech. Sustainability, quality, and competence. Listen to some of our employees talk about how we work.
Take your product through the regulatory process
The regulatory requirements for medical devices mean that it is important to have correct documentation throughout the entire development process. Our employees guide and carry out what is required regardless of whether you hire us for the entire product development or just need support with the regulatory parts.
Do you need help with risk analysis assessment? Read more about our offer Risk Analysis for Medtech
We tailor projects based on your needs
Our customers are found in most areas of therapy, and range from start-ups to large corporations. Among others, we have worked on projects that improve childbirth monitoring, prevent migraines and provide safer radiotherapy.
Each assignment begins with a conversation where we identify your needs. We then tailor our proposals. Our main strength is that we have expertise in both regulatory concerns and product development.
Experienced engineers receiving special training
We can offer experienced engineers in Medtech, mechanical engineering and textile technology, electronics and software development. We also have specialists in plastic construction and biocompatibility. All technical experts who work in Medtech are also trained in our own development process.
Examples of areas where we work
- Respiratory aid
- Advanced wound care
- Urology
- Radiation treatment
- Childbirth monitoring
- Hearing aids
- TAI - transanal irrigation
- Migraine treatment
- Alarm system
- Sterilisation
- Dental implants
- IVF
- Simulation of endovascular therapy
- Equipment for neurosurgery
- Cancer diagnostics
The regulatory processes
We have extensive experience in supporting companies to implement regulatory processes for applications both within Europe and the North American market. We work with products in all risk classes according to the MDR. You can hire us to get help with planning certification or developing your quality systems.
Medical standards we work with
Customers who struggle to interpret the standard requirements can rely on us for solutions that drive the project forward.
We work on a daily basis with:
- EN ISO 13485 (management system)
- EN ISO 14971 (risk management)
- IEC 62366 (usability)
- IEC 62304 (software life cycle process)
- IEC 60601-1-serien (basic safety)
Do you want to know more? Contact us
Medical technology – a growing industry of the future that saves lives
Medtech is one of our largest business areas. It is an industry of the future that is steadily growing and that feels particularly meaningful to work in as the products are used to save lives through diagnosis, monitoring and treatment. We would love to have even more colleagues with a passion for medical devices - are you one?
We are partners of Swedish Medtech and Norway Health Tech
Reach out for more information and contacts!
