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Is your idea the next game-changer?

Together we create the next generation of medical technology

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Together we create the next generation of medical technology
Together we create the next generation of medical technology
Product Development

Product Development

Our development team helps you turn your medical device product ideas into reality.

UI/UX, iOS, Android, webb, backend...

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Regulatory Services

Regulatory Services

We have many years of experience and are a reliable partner in QA and RA, with cutting-edge expertise in software.

CE Marking, MDR, IVDR, FDA...

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Quality Management - Training, coachingand change management

Quality Management

We help you quality assurance, processes and documentation in your medical device operations.

ISO 13485, QMSR, EN 62304, eQMS...

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Information Security

Information Security

We help you implement an information security management system tailored to your needs.

NIS2, ISO 27001, IEC 81001-5-1...

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We are specialists in mobile apps, modern web applications, and integration solutions in medical devices, taking your ideas all the way to a CE-marked medical device.

We can onboard your product idea and start a development project with full medical device management.

We can onboard your product idea and start a development project with full medical device management in a cost-effective way, allowing you to grow into your role as a manufacturer at your own pace. If you need development resources, we are by your side.

  • Trusted Development Partner

  • Proven Project Model

  • Agile Methodology

  • All the way to market

Now we need to strengthen our team!

› App and Web Developer with a sense for UX
› Consultant in Quality and Regulatory Affairs for Medical Technology

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Webinars

Here you can find the webinars that have been held by Focalcube in collaboration with Key2Compliance.

CAPA

In this webinar, we will go through how a medical device manufacturer can manage a CAPA, that is, corrective and preventative actions. We will cover the requirements from MDR, FDA, and ISO 13485, and provide a practical example of how it can be documented and managed with the help of Focalcube.

Change management

In this webinar, we will go through what to consider when implementing a change in your medical device product. We will cover the requirements from MDR, FDA, and ISO 13485, and provide a practical example of how to use Focalcube to document your change in a way that meets the requirements.

Five Success Factors for Startups in Medical Device Software

Do you have an amazing product idea in the works?

We have worked with many innovation companies over the years. Here, we share some of what we've learned. Feel free to check out the article and reach out if you'd like to discuss how we could assist you!

GUIDE: FIVE SUCCESS FACTORS

Medical device