Bordercross Health provides a platform that automates DCB0160 documentation and streamlines clinical safety management for digital health technologies. It enables automated generation of safety reports and hazard logs, and facilitates workforce engagement through virtual workshops to ensure ongoing compliance and risk mitigation.
Funding
Funding not disclosed
Founders
Product
Problem
Ensuring continuous clinical safety for digital health technologies throughout their lifecycle presents significant documentation and workforce engagement challenges. Traditional methods for DCB0160 compliance are time-consuming and often fail to involve the frontline staff who possess critical insights into operational risks.
Solution
Bordercross Health offers an end-to-end platform designed to automate and streamline clinical safety processes for healthcare technologies. The system automates the generation of essential DCB0160 documentation, including Clinical Safety Case Reports and Hazard Logs, freeing up clinical leads to focus on review and approval. Furthermore, it facilitates workforce engagement through virtual hazard workshops, empowering staff to contribute directly to risk management and product safety. This approach ensures ongoing compliance and efficient risk mitigation across all phases of a digital health product's lifecycle, from development to decommissioning.
Target Audience
The primary customers are digital health technology providers and healthcare organizations, particularly those operating within the NHS, requiring robust DCB0160 compliance and continuous clinical safety management.
Features
- Automated generation of DCB0160 documentation: Clinical Safety Case Reports, Clinical Risk Management Plans, Hazard Logs, and Post-Deployment Monitoring Reports.
- Virtual hazard workshops to engage and collaborate with the entire workforce on digital change safety.
- Continuous clinical safety monitoring and management throughout the technology lifecycle.
- Centralized hazard log management and updates.
- Decommissioning report generation.
- Platform trusted by digital safety leads within the NHS.