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.

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.

Alexandra Schroeder, PhD, is Associate Global Head of Vascular Devices at BSI and has been with BSI since 2014.  Prior to BSI, Alexandra worked for several years in Product Development for vascular stents at Cook Medical. Alexandra holds several US patents for medical devices and is a contributing author in 10 peer-reviewed research publications.  As a technical specialist for BSI for many years, Alexandra managed CE Marking certification schemes and was a technical reviewer for vascular devices including stents and other catheter-based devices.  She was co-reviewer on BSI’s first issued Class III product certificate under MDR and has presented at numerous internal and external conferences on topics related to the EU Medical Device Regulation and notified body assessments. As Associate Global Head of the Vascular Devices team, Alexandra supports notified body reviewers conducting conformity assessments of a variety of devices against the requirements of EU MDR, UKCA, and continued transition of EU Directives.

John Bis has over over 32 years of experience in the healthcare industry, John Bis is a trusted leader and collaborator in the global medical sector. He works closely with professionals and organizations worldwide to deliver high-impact solutions that support the successful development and launch of quality healthcare products.

As a senior leader at BSI, John ensures clients receive comprehensive services including regulatory assessments, CE marking, training, and expert technical reviews. He also leads a dynamic team of business development managers dedicated to helping organizations achieve excellence in an increasingly complex healthcare environment.

John brings a wealth of knowledge, real-world insight, and a passion for quality to every conversation—making him a sought-after voice on topics related to regulatory compliance, market access, and healthcare innovation.