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Digital Health Services

We are a full-service provider offering regulatory and medical device consulting, CRO services and data management consulting. Our dedicated team of digital health and medical device professionals is here to support you from medical software development and data management to regulatory planning and quality assurance.

There are increasing quantities of software as a medical device or as part of a device, possibly involving AI, IoT, mobile apps, or telemedicine. At the same time, there are growing regulatory requirements for medical software and health data management, along with information security concerns. We help medical device developers to tackle these challenges.

At Labquality, we have a dedicated team for digital health solutions. The in-house software focused regulatory experts and software developers under the same roof to support your project needs, and understand the world of digital health solutions, how these are developed, what tools are needed and how these are addressed.

Our digital health team focuses on providing these types of services

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Regulatory and Quality Assurance services
  • Regulatory planning in line with EU, FDA, or any other regulation to ensure your product meets all the requirements.
  • Creating software development environments that can be connected to a chosen Quality Management system (QMS)
  • Building an Electronic Quality Management System (eQMS) such as scilife.io.
  • Integration of Jira/Confluence workflows into the electronic QMS (eQMS).
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Development services
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Platform services
  • Setting up cloud environments (dev/prod).
  • Modifying Jira/Confluence to support medical device development.
Mika Siitonen

Contact us for more information

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Mika Siitonen
Head of Digital Health
contact-email
mika.siitonen@labquality.com

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