Welcome to Hotswap!

At Hotswap engineering consultants we have a strong passion for life science technology and medical device development, from connectivity to brain surgery. We offer all services needed for conception, development and design transfer to production in close cooperation with our customers. Turn-key or on-site. And we are certified according to SS-EN ISO 13485:2012 (Stockholm and Lübeck). Working together as a team with software, mechanics, electronics and regulatory, bringing the maximum benefit to our customers. Medical Device Development – that´s what we do every day.

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Hotswap ISO 13485:2012 certification

Today we proudly received our renewed ISO13485:2012 certificate for contract design and development of active and non-active medical devices.

Are you developing a mobile app for the US market?

If your mobile health app collects, creates, or share consumer information this interactive tool will help you find out which regulations from Federal Trade Commission (FTC), Food and Drug Administration (FDA), and Office of Civil Rights  (OCR) will apply to your device.

House Warming in new Kista Office

We welcome all our customers and partners to our new office in Kista.

Connectivity + Medical Devices

There is a rapidly increasing demand for connectivity in medical devices. Care providers want patient data automatically transferred to electronic record systems. Medical device manufacturers ...
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Are you in control of regulatory?

Regulatory management for us means to ensure product safety and fulfilment of regulatory requirements in order to launch your product. We have the regulatory and ...
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How can we help your business?

Contact one of our sales managers closest to you and discuss your challenges and needs. Big or small. 

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Take the step and join our team!

Do you want to work in an exciting company and have experience of software, electronics, mechanics, industrial design, project management, regulatory or other relevant background? Take the step and join our team!

Apply here