Giovanni Milandri, Medical Devices Development, Quality and Regulatory Compliance Advisor

Giovanni Milandri is an expert in research and development of medical devices and Quality/Regulatory (QARA) management. His main expertise is in design and trialing of medical devices to move from the lab to the clinic, and to regulatory approval. He has a substantial track record which includes over ten devices and six clinical trials, with over 20 patents and publications. He has worked in four start-ups, one of which was a successful exit for an orthopaedic tool, now with a history of over 4000 operations.

Giovanni has a post-doc from Imperial College London, PhD in rehabilitation from UCT and a MSc from University of Oxford. He has designed products ranging from robotic prosthetics, orthopaedic surgical tools, software as a medical device (SaMD), post-surgical rehabilitation and global surgery devices. He provides expert support to MedTech projects in practical application of quality assurance and regulatory affairs (QARA for compliance with ISO 13485 quality management systems, ISO 14971 Risk Management, GCP, IEC 62304 in SaMD, and AI as a medical device).