RAPS Euro Convergence is an annual conference created by European regulatory professionals for regulatory professionals operating in Europe and other countries who want to comply with European regulatory policies.

The 2021 programme provided a specific forum for leading experts and professionals in the medical device, IVD, and pharmaceutical industries to examine and provide insight on the most urgent and crucial issues facing regulators, manufacturers, and regulatory professionals working with healthcare products for the European market.

The 2021 conference was held ‘virtually’ from Friday 7 May to Wednesday 12 May, with a wide selection of speakers from the drug, device and IVD sectors. At 10:00 on Tuesday 11 May, Donawa Lifescience’s President, Dr Maria E Donawa, M.D. was co-speaker with Danielle Giroud, President of MD-Clinicals, on the subject: ‘Risk Management: Compliance with Risk Management Requirements in ISO 14155:2020 During Different Clinical Development Stages of Clinical Investigations for Medical Devices, Including SaMD’.

Dr Donawa explained that ISO 14155 has been updated to include increased risk management requirements throughout all phases of clinical investigation planning and conduct. The first presentation in this session provided an overview of the increased risk management requirements and what this means in practice. The second presentation provided specific examples and methods for complying with the revised standard, including the new risk management requirements.