Reliable and dependable devices save lives

Health technology and medical devices

Our expertise in medical devices covers all areas of product development, from early-stage design and usability evaluation through to supporting the production ramp-up phase. In addition, our specialists have extensive experience of standards related to medical devices.

Reliable and safe medical devices and software

Above all, medical devices must be reliable and ensure patient safety. Usability plays a central role, as devices are often used in demanding and critical care environments. Health technology increasingly makes use of new technological solutions such as machine learning and data-driven decision-making, which places specific requirements on both the devices themselves and the supporting software.

Our comprehensive health technology expertise spans the design of medical devices from industrial design through to mechanics, electronics and software. We understand the regulatory requirements of the sector and have strong capabilities in functional safety, information security and risk management. We recognise how critical device reliability and the protection of patient and health data are throughout the entire lifecycle of a device.

Our customer solutions are used, among other things, in asthma diagnostics, quantitative and qualitative measurements, detection of molecular pathogens, intelligent access control, efficient allocation of care resources and nurse call systems.

We help ensure the safety of medical devices

Compliant product development

We help develop medical device software and digital solutions, ensuring that safety and regulatory requirements are integrated into the development process from the outset.

  • ISO 13485 certification
  • IEC 62304 software standard
  • IEC 60601-1 medical electrical equipment standard
  • ISO 14971 standard
  • IEC 62366 usability standard
  • IEC 82304
  • MDR and IVDR

Cybersecurity and connected devices

We address cybersecurity throughout the entire product lifecycle. Our expertise covers secure development practices, threat modelling, security testing, and the security of connected medical devices and cloud services.

Software and SaMD

We design and develop medical device software, Software as a Medical Device (SaMD) solutions and related digital services. We integrate software development, quality and regulatory compliance into a unified development process.

Data, AI and integrations

We help organisations leverage data, AI, cloud services and integrations in medical devices and digital health solutions. We build solutions that bring devices, software and backend systems together into a seamlessly managed ecosystem.

Usability and safety

Good usability is an essential part of medical device safety. We support user interface design, prototyping and usability testing, as well as usability engineering in accordance with IEC 62366.

Business and technology transformation

We help health technology companies turn strategy into action and manage digital transformation. We support leadership and change management, develop agile ways of working, and design architecture and cloud solutions that support business objectives.

Contact us

Kosti Niemelä

Account Executive

kosti.niemela@gofore.com

+358 40 766 0654

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