Case Study: Delivering Clinical Safety and Risk Management for Start-ups

Background: The Journey Towards Compliance and Safety

GeneralPractice.AI is a healthtech start up which was eager to bring their innovative software to market. They faced the daunting challenge of ensuring compliance with stringent clinical safety standards. Specifically, they needed to complete the DCB0129 and DCB0160 documentation to meet NHS England (Digital) requirements. Additionally, they sought to establish a robust Risk Management System to ensure the safety and reliability of their product.

With limited internal resources and a tight budget, the GeneralPractice.AI turned to us for expert guidance. They also intended to leverage a third-party software tool called NAQ to streamline their documentation process and sought our support in integrating this tool effectively.

Our Approach: Seamless Collaboration and Expert Guidance

1. Comprehensive Clinical Safety Review:

• Conducted a detailed review of GeneralPractice.AI ’s clinical safety processes, identifying gaps and areas for improvement.

• Developed a roadmap for achieving compliance with DCB0129 and DCB0160 standards.

2. Documentation and Compliance Support:

• Successfully prepared the Clinical Safety Case Report, including:

  • Hazard log development.

  • Safety impact assessments.

  • Clinical risk mitigation strategies.

  Drafted and finalised DCB0129 and DCB0160 documentation tailored to the GeneralPractice.AI’s product and clinical workflows.

3. Risk Management System Development:

• Performed a thorough risk management review and conducted hazard analysis to identify potential safety risks.

• Formulated a comprehensive Risk Management System in line with DCB0160/0129, ensuring a structured approach to identifying, assessing, and mitigating risks.

4. Synergistic Collaboration with Third-Party Software:

• Worked closely with the GeneralPractice.AI ’s chosen third-party software provider - NAQ to ensure seamless integration and effective use of the tool.

• Facilitated communication and collaboration between the GeneralPractice.AI and the software provider, ensuring key deliverables were met on time.

• Provided training and guidance to the GeneralPractice.AI ’s team on using the third-party software to maintain clinical safety documentation efficiently.

Outcomes and Benefits

1. Comprehensive and Compliant Documentation:

• Delivered fully compliant DCB0129 and DCB0160 documentation, enabling the GeneralPractice.AI to confidently present their product to healthcare stakeholders and the NHS.

2. Cost-Effective Solutions:

• Provided expert services at an accessible price point, helping the GeneralPractice.AI achieve compliance without exceeding their budget.

3. Robust Risk Management System:

• Developed a future-proof Risk Management System, equipping GeneralPractice.AI with the tools and processes needed to manage clinical risks throughout the product lifecycle.

4. Efficient Workflow and Key Deliverables:

• The collaboration between GeneralPractice.AI, third-party software provider, and our team resulted in a smooth, efficient workflow that saved time and ensured all deliverables were completed to the highest standard.

Client Testimonial

"I had the pleasure of working with Yasmin Karsan as the Clinical Safety Officer for our GeneralPractice.AI application. Yasmin’s thorough and attentive approach, combined with her extensive knowledge of clinical safety, made a significant impact on our project. She provided valuable insights and practical suggestions that not only improved the overall safety of the product but also helped to steer our development in the right direction. Yasmin was always accessible and friendly, making collaboration straightforward and productive. I would highly recommend her to any organisation seeking a dedicated and skilled clinical safety professional."

– Dr Angus Perry – Founder of GeneralPractice.AI

Conclusion: Supporting Innovation with Expert Compliance Services

For GeneralPractice.AI , we delivered more than compliance—we provided peace of mind and a solid foundation for success. Our flexible, budget-friendly approach and ability to work synergistically with third-party tools made us the ideal partner for their clinical safety and risk management needs.

If your start-up is navigating the complex world of clinical safety and regulatory compliance, we’re here to help. Let’s ensure your product is safe, compliant, and ready for market.

Contact us today to get started!