AI Safety and Risk Management 

Navigating new AI regulations and technical standards can be challenging. We offer comprehensive AI safety assurance and risk management programs to help you overcome these hurdles. We will implement an AI safety assurance framework, conducting thorough risk assessments of your AI systems, and guide you through the development, evaluation and deployment process. 

Consultancy - Medical Device Software & SaMD

With many years of experience in software development and life cycle management, design control, and risk management, we are well-equipped to guide you through the complexities of technical standards such as IEC 62304, IEC 62366, and ISO 14971. Our bespoke frameworks and procedures are tailored to seamlessly integrate with your development life cycle, ensuring design assurance and safety at every stage. 

• Software Design and Development Planning

• Hands-on safety and security risk analysis 

• Apply design control principles: requirement definition, design, development, verification and validation and traceability.

• Technical documentation

• Change Management and Maintenance 

Gap analysis and Audits

We can perform gap analysis and audit of your Design History File (DHF) and technical documents against the requirements in ISO 13485, ISO 14971, IEC 62304, IEC 62366 and Security standards.

Training and Education

We offer comprehensive training, customizable templates, and interactive workshops to support your software development, design assurance and risk management needs. 

Our expert-led sessions are designed to help your team master technical standards, design control, and risk management principles.