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We’re developing medical devices that make it easier to feel better. And live our lives the way we want to. Technology that’s easy to use, safe and connected, giving the best possible user experience.

Anna Nordelöf, Semcon

Anna Nordelöf

Area Manager

Quality Management Göteborg

Case studies

Learn more about our capabilities and previous projects.

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Medical products are products that we get up close to: users, patients, medical personnel. They can make the difference between life and death. Or they can help you live the life you’ve always wanted to live. Such products have to make a real difference to people’s lives, whether they’re used at medical facilities or in the home. Because we’re convinced that the user experience is the true indicator of quality.

Innovative design for simple, effective use

Today’s rapid technical development means that users are making more and more stringent demands in terms of design and user friendliness. New technical solutions are stretching the boundaries for the use of prosthetic knees, hearing aids and wheelchairs. Medical devices no longer need to prevent people living full, active lives. Semcon has a unique position in the industry in this respect, partly thanks to Semcon Studios, our in-house development department where we combine design, technology and focus on users.

At Semcon Studios we work in cross functional projects and in close collaboration with the customer – providing our collective competences.

Johanna Stenfeldt, Country Manager Sweden West

Compliance and patient safety

As Life Science is governed by strict regulations and specific standards to increase safety, the development and producing new products can be a long and complicated process. Semcon has a great deal of experience of validation and quality assurance in medtech primarily based on ISO 13485 and MDR. This means, among other things, that we help our customers ensure quality and streamline the process of getting their medical technology products to market. So that end users can benefit from new, smarter products as soon as possible.

"Strict requirements and regulatory frameworks that are constantly changing make it vital to have functioning processes in place. At Semcon, we help our clients to relate to the ISO 13485 regulations, for example, that are applicable to medical devices. The aim of this is to allow them to devise safe, user-friendly products in an effective way."

Sara Sjögren, Country Manager Sweden East & South

Smart digital solutions

Connected medical devices pave the way for new opportunities: for users in a home environment, and at medical and healthcare facilities. But what’s the best way of connecting a product? Digital solutions have a number of potential advantages; such as more efficient monitoring for both patients and medical personnel, who can track results remotely. There’s also a degree of security for users of products that index themselves, for example, and issue alerts when spare parts or batteries need to be replaced.

In today’s personalized society, we are focusing more on tailor-made solutions. For medical devices, digital solutions can provide the difference that makes it possible to live the life you always wanted.

Johan Kristensson, Team Manager Software & Architecture

Selection of competencies:

  • QA, QM, QC, QMS (MDR, ISO 13485 & ISO 62304)

  • User studies and concept development

  • Verification and validation

  • Software development (Embedded, Cloud, Application development)

  • Mechanical construction

  • Design and UX/UI

  • Cyber security

  • Electronics construction

Contact us

Elin Sins, Semcon

Elin Sins

Area Manager

Life Science / Project Excellence & Management

Anna Nordelöf, Semcon

Anna Nordelöf

Area Manager

Quality Management Göteborg