Founder and Lead QARA Consultant at QRA Medical, supporting MedTech and digital health teams with EU MDR, UKCA, FDA strategy, ISO 13485 QMS, ISO 14971 risk management and software lifecycle compliance (IEC 62304). Host of The MedTech Podcast, and a judge for MedTech Innovator and MassChallenge. I help early stage and scaling companies turn product plans into regulator ready documentation and pragmatic systems that move programs forward.