Peter founded two medical device companies in the cardiorespiratory area and exited both with a trade sale. In 2013 Dr Donnelly co-founded MedZone Solutions, a consultancy services company that provides Quality Management Systems and Regulatory advice and support for Medical Device compliance (in Europe and the US etc.) with specialist knowledge in medical software standards and regulations. He is also a Founder, Director and CEO of Tapa Healthcare DAC which is a medical software company developing and commercialising a patient safety system that enables Early Patient Intervention.
Webinar 3 "Medical Device Regulation EU". Peter Donnelly, MedZone Solutions will explain what MDR is, how to comply, the benefits of compliance and the consequences of non-compliance. Aidan Boran, GaitKeeper.ie, will discuss his journey through the MDR framework to having GaitKeeper classified as a Class 1 medical device.
eHealthEmbark Module 2 takes place on 5th May. Peter Donnelly of Medzone Solutions and Tapa Healthcare DAC will guide participants on medical device validation and software regulation. Daniel Kyne of OpinionX will do a deep dive into Customer Discovery through to Customer Validation.