About the Author

Radoslav Milkov, LL.M., is the founder and Managing Director of QLE Group, a Brussels-based regulatory and quality consultancy supporting medical-device and health-technology companies across Europe and internationally.

Rado specialises in EU medical-device regulation, ISO 13485 quality management systems, clinical investigations, post-market surveillance, risk management and market-access strategy. He advises manufacturers on navigating the EU MDR and IVDR, CE marking, authorised representation, PRRC responsibilities and interactions with notified bodies and competent authorities. His experience also extends to FDA regulatory pathways, data protection GDPR & Privacy compliance and the regulation of software and artificial intelligence in healthcare.

Through the QLE Regulatory Brief, Rado provides practical analysis of important regulatory developments—explaining not only what has changed, but what manufacturers and other economic operators should do next.