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.
Our digital health team focuses on providing these types of services
Regulatory and Quality Assurance services
- Regulatory planning in line with EU, FDA, or any other regulation to ensure your product meets all the requirements.
- Building an Electronic Quality Management System (eQMS) such as scilife.io.
- Integration of Jira/Confluence workflows into the electronic QMS (eQMS).
- Support in software development with Labquality’s in-house software developers specializing in medical device software.
Proof of concept
- Data management services to ensure the handling of even the most sensitive information securely and in compliance with GDPR.
- Full technical documentation creation for your device
- Setting up cloud environments (dev/prod).
- Modifying Jira/Confluence to support medical device development.