Clinical Risk Management – DCB 0129 & 0160 Support

Overview

Navigating the complexities of DCB0129 (for manufacturers) and DCB0160 (for healthcare organisations) is crucial for the safe deployment of health IT systems. We offer comprehensive support to help you understand, implement, and maintain compliance with these mandatory standards, and we provide end-to-end clinical safety and compliance support for healthcare organisations and health tech companies. Our services are designed to ensure your digital health products meet all necessary regulatory standards while maintaining the highest levels of patient safety.

Who It’s For

Digital health startups, established healthcare IT providers, and NHS trusts looking to implement or upgrade their digital systems safely.

Key Benefits

• Mitigate clinical risks early in the development cycle
• Ensure compliance with UK and international healthcare standards
• Build trust with healthcare providers and patients
• Streamline the deployment process
• Expert guidance through the entire compliance lifecycle
• Development of robust Clinical Safety Case Reports and Hazard Logs
• Independent clinical safety reviews
• Ongoing support to maintain compliance post-deployment