Medtech Industry

Experts in Medical Device Development

For more than 25 years we have supported Medical Device manufacturers with Product development. These projects have resulted in products and solutions used for diagnostics, monitoring or treatment in both clinical settings and home environment. We have developed a large number of systems including electronics, software and mechanics, but also stand-alone software, mobile applications, cloud services and disposable products in various materials such as textiles or non-woven. Medtech is today one of our largest sectors.

Customer Projects

Our customers are manufacturers of medical equipment but also research institutes, academia and care providers. We are contracted by both startups and larger global companies. Areas we operate in, among others, are:

  • Respiratory aids
  • Advanced wound care
  • Urology
  • Radiation therapy
  • Childbirth monitoring
  • Hearing aids
  • Alarm systems
  • Sterilization
  • Dental implants
  • IVF
  • Simulation of endovascular therapy
  • Neuro surgery equipment

Regulatory Requirements & Certification

Joint for medical devices are the regulatory requirements. The purpose is to ensure that patients and users are not exposed to unnecessary risks, which means that all medical device products must have documentation that proves that it is safe and complies with laws, standards and safety regulations. We have extensive experience in driving the certification process on behalf of our customers and guide in issues related to electrical safety or environmental testing. We work with products within all product risk classes according to MDR (class I, class IIA, IIB and class III.) 

Medical Device Standards

All medical device development is regulated by standards, general and/or product specific. For the customers who need advice on how to interpret the standard requirements, we find solutions that take the project forward. Among the general medical device standards that we comply with in our everyday work are EN ISO 13485 (management system), EN ISO 14971 (risk management), IEC 62366 (usability), IEC 62304 (software lifecycle software), IEC 82304 (Health software) and several of the standards of the IEC 60601-1 series (electrical safety). 

From User Needs to Market Access

For those customers who want to outsource the design work to an external party, we can take leadership for managing the entire development process, from identifying user needs, risk management, detailed design and production set-up to certification and product approval for different markets. Our organization includes many different competencies and for each project we form the team that is needed.  We have processes, equipment and premises adapted for medical device projects and our quality management system is certified according to ISO 13485.

After a product has been developed and launched, we may support in optimizing production, new product functions, approvals for new markets or Cost reduction as the product approaches end of life. For those customers who need resource reinforcement, our consultants are hired during a project to be part of a team at the customer where the customer leads the project.

Anna Axelsson
Regional Manager Göteborg/Trollhättan
Mikael Duvander
Business Unit Manager Electronics and Medical Device
Claes Jonsson
Business Unit Manager Medical Device