Digital Health Solutions for Wearable and Implantable Medical Devices

Creating digital health solutions around wearable and implantable medical devices allows for the collection of data that will unlock the full value of these devices and improve patient and clinician experience.

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Needs analysis and value proposition definition and validation
Regulatory and reimbursement pathway definition
Service design
Software as a medical device (SaMD) development
Software development of end-to-end integrated devices, mobile applications, portals, and cloud-based solutions
Operation and management of service and solution

By analyzing all stakeholder needs we define a clear value proposition and develop digital health solutions around medical devices that will secure regulatory certification and reimbursement.

We take medtech companies from concept, through development, and on to product launch and management under our certified ISO 27001 managed services. Our Affinial platform provides a secure foundation, while our proven process and certified quality management system ensures a quick and efficient path to market.

Digital Health Solutions for Wearable and Implantable Medical Devices

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