Colm O’Rourke is a seasoned medical device professional with 13 years of experience spanning notified bodies, diagnostics manufacturing, and clinical laboratory settings. For the past three years, he has worked as a quality and regulatory consultant, helping medical device companies achieve compliance through strategic planning, the development of robust technical and quality documentation, and regulatory submissions—including managing deficiency responses to notified bodies.

Based in Sydney, Australia, Colm leads the Australian Sponsor Service for MDSS, supporting international manufacturers in registering their medical devices with the Therapeutic Goods Administration (TGA) to enable market entry in Australia.

Colm holds a BSc in Biomedical Science from University College Cork (UCC), Ireland, and a Diploma in Medical Device Science from NUI Galway, Ireland.

Yuan Li holds a doctorate degree in Mechanical Engineering. His research at the University of Memphis and the University of Tennessee Health Science Center produced 13 peer-reviewed publications on spinal pathologies and novel implants.

After entering the medical device industry, Yuan specialized in Regulatory Affairs, managing product approvals/clearances (510K, CE certification) across the US, EU, and APAC regions. He moved into notified bodies in 2015, initially as an Orthopedic product reviewer and lead auditor, later advancing to management roles. He currently oversees North American operations at DQS, supporting market expansion and regulatory compliance.

Sumatha is a senior quality business partner at Qualio, supporting Qualio’s regulated life science customers with targeted support to help them optimize their quality systems and embed lasting compliance. She has over 20 years of QA/RA experience across the medical device and pharmaceutical sector, and has built quality management systems for compliance with the FDA QSR, Canada’s Medical Devices Regulations, NIOSH, MDSAP, COFEPRIS, and the EU’s MDR, IVDD and IVDR. She holds a Master’s in Chemistry and an advanced certificate in quality assurance management, along with auditor certifications for ISO 13485, 17025, ISO 27001, ISO 9001, IATF 16949.