Catriona Boyd

Catriona Boyd has been helping companies bring innovative medical technologies to the market for over 15 years. Today, she is the Founder and Principal Consultant of IlluMed Advisory Inc., where she works as a fractional executive and quality and regulatory advisor to MedTech startups.

Catriona’s career has given her perspective from both sides of the table, having worked for both manufacturers and consulting companies. She has led Quality and Regulatory departments at Thornhill Medical and Chipcare Corporation, with experiences spanning early-stage research and development through the product life cycle to post market surveillance and reporting. She also served as Director of Quality Services and Senior Consultant at Ironstone Product Development (IPD), Canada’s only full-service medical device consulting group, and Avania, who acquired IPD in 2023. That mix of in-house and consulting experience shapes how she approaches problems: she understands what it’s like to be the person accountable, not just the advisor in the room.

Catriona has built and maintained Quality Management Systems compliant with ISO 13485, MDSAP, FDA QSR/QMSR, CMDR, MDR 2017/745, IVDR 2017/746, and has a track record of securing investigational and market authorizations across global markets.

She has a Bachelor of Applied Science in Engineering Science, Biomedical Engineering from the University of Toronto, a professional engineering designation (P.Eng), and is certified as a Regulatory Affairs Professional (RAC-Devices), Certified Biomedical Auditor (CMDA), TPECS Lead Auditor, and ISO 13485:2016 Internal Auditor.