Building Confidence Early: Feasibility Testing and ISO 13485 Essentials for Medical Innovators (QBoost AP1 Workshop Series #1 2025/2026)

​Developing a new medical device is an exciting journey, but many ideas fail to advance because feasibility and regulatory considerations are overlooked in the early stages. This workshop provides innovators, researchers, and entrepreneurs with a practical roadmap for feasibility testing of new medical device concepts, while introducing the fundamental requirements of ISO 13485:2016, the international standard for medical device quality management systems.

​Short Bio of presenter(s): 

​Dr. Sindhu G. Nair is an accomplished Quality Management Systems (QMS) expert, ISO Assessor, and Quality Consultant with extensive experience in quality assurance, risk management, and regulatory compliance for the medical device and healthcare industries. She is the CEO and Co-Founder of Q Boost Inc., and QPilots Inc., a quality consulting and quality software  firm based in Edmonton, Canada, specializing in ISO 9001, ISO 13485, ISO 17025, ISO 15189, and CLIA compliance.

Dr. Nair has led the successful implementation and auditing of electronic QMS (eQMS), Laboratory Information Management Systems (LIMS), and QR-coded inventory solutions for research labs, start-ups, and medical device companies across North America. She has played a pivotal role in helping organizations achieve ISO and CLIA certifications with zero non-conformances while streamlining quality systems for efficiency and growth. Dr. Nair contributes to the global standards community as a working member of ISO TC 212, the Standards Council of Canada (SCC), and the Canadian Standards Association (CSA Z252). With a Ph.D. in Chemistry from the University of Alberta and a Master’s in Analytical Chemistry, her research background in analytical techniques, DNA damage detection, and metabolomics complements her regulatory expertise—bridging the gap between technical innovation and quality compliance.