Ensuring the quality and safety of your healh AI and SaMD products 

Ranj Zuhdi - Principal Consultant / Founder 

With 18 years of experience in the regulated digital healthcare sector, Ranj Zuhdi is a seasoned software quality and design assurance engineer and consultant. His diverse background spans large MedTech companies developing medium to high-risk medical devices, Digital health, AI systems and SaMD (Software as a Medical Device).

Ranj has extensive experience in developing software and quality processes from product inception to deployment and monitoring. He is an expert in implementing software design assurance and quality systems compliant with ISO 13485 and FDA's Quality System Regulation, and is proficient in ISO and IEC standards, agile development and testing, risk analysis, verification and validation, and cybersecurity risk management.

Recently, Ranj has been contributing to the development of technical AI safety standards through his involvement with national bodies and EU standards organizations. He applies his MedTech experience to research on integrating AI safety within new and existing regulatory frameworks.

Additionally, Ranj dedicates time to mentoring and providing guidance to digital health startups in the UK and EU.