We develop custom electronics and embedded systems designed for precision, safety, and long-term reliability, ensuring compliance with medical standards.
We provide low-power medical electronics, sensor integration, battery management, wireless communication (BLE, Wi-Fi, NFC), and PCB design for medical applications—ensuring optimal performance and patient safety.
We build embedded and application-level medical software that complies with IEC 62304, ISO 13485, and FDA software validation requirements.
We provide real-time control software, GUI development, cloud-based medical applications, cybersecurity implementation (IEC 81001-5-1), and software verification & validation (V&V)—ensuring reliable, regulatory-compliant solutions.
We integrate AI-driven decision-making into medical devices for predictive diagnostics, real-time monitoring, and automated analysis, ensuring faster and more accurate clinical insights.
We provide edge AI for medical devices, predictive analytics, real-time anomaly detection, medical image processing, and AI model validation for regulatory approval—enhancing clinical intelligence.
We develop and test functional prototypes to validate design decisions, ensuring reliability, safety, and manufacturability before regulatory submission.
We provide rapid prototyping, pre-clinical testing, biocompatibility assessments, mechanical and environmental stress testing, and EMC/EMI compliance testing (IEC 60601-1-2)—helping devices pass rigorous medical approvals.
We apply human factors engineering to ensure that medical devices are easy to use, minimize risk, and comply with usability standards (IEC 62366-1).
We provide usability testing, user interface (UI) design, risk-based workflow optimization, clinician and patient feedback integration, and documentation for regulatory submissions—ensuring devices are designed for real-world use.
We design wireless medical devices that comply with cybersecurity and patient data protection standards, ensuring reliable and secure data transmission.
We provide Bluetooth Low Energy (BLE) integration, medical IoT (IoMT) architecture, encrypted data communication, FDA/CE cybersecurity compliance, and cloud-based health data management—bridging the gap between devices and digital healthcare.
Bringing a medical device to market requires strict adherence to regulatory frameworks such as FDA, MDR, UKCA, and ISO 13485. We integrate compliance into every stage of development.
We provide regulatory gap analysis, documentation for CE/FDA approval, risk management (ISO 14971), clinical evaluation report (CER) guidance, and QMS implementation (ISO 13485)—ensuring a smooth regulatory pathway.
Company Name: HoloCare AS
VR Healthcare Start-up
The Target
The Outcome
The Work
