Staying safe in the Internet of Medical Things (IoMT)

Software and hardware developed by experts

tuomi has been developing medical software products that comply to the European Medical Device Regulation (EU MDR) since 2016. We offer software services for cloud and mobile applications as well as engineering for medical hardware.

Our engineering and development always fulfils all relevant standards, including:

  • Medical Device Regulation 2017/745/EU

  • ISO 14971:2019: Medical devices - Application of risk management to medical devices

  • EN 62304:2006 + Cor.:2008 + A1:2015: Medical device software - Software life cycle process

  • IEC 62366-1:2015 + AC:2015: Medical devices

  • IEC 82304-1: Healthcare software

Expert advise

We do more than just provide support and expert advice. We always work closely with you to implement your specific medical project. And after 5 years of experience with the new EU Medical Device Regulation, our customers and partners know they can rely on a team that has a lot of experience with the EU MDR environment.

QMS Certified according to ISO 13485

We are only ever satisfied with the highest quality, so that is exactly what we offer our partners and customers. The high quality is guaranteed through the processes and goals we have established within the company.

We are certified according to DIN EN ISO 13485:2016.

Blog

  • Dr Enise Lauterbach becomes tuomis new Medical Director

    Dr Enise Lauterbach becomes tuomis new Medical Director

    Dr Enise Lauterbach, a well-known German doctor and award-winning founder, joins the IT specialist tuomi. As Medical Director, she will take on an advisory role and support tuomi in developing further highly specialised medical software for medical staff and patients.
  • Successful internal audit for QMS according to ISO 13485:2016

    Successful internal audit for QMS according to ISO 13485:2016

    For us, the certification of our quality management system according to ISO 13485:2016 was only the first step. After receiving the certificate, the work for us did not stop at all, but rather it has only just begun.
  • Living QMS in a SME

    Living QMS in a SME

    tuomi has implemented a Quality Management System based on ISO 13485:2016. It has some unique challenges to live QMS in an owner-managed company. Long-established processes are questioned and potentially improved.