Edwin Lindsay

Edwin Lindsay is principal consultant and managing director at CS Lifesciences, a regulatory, quality, and clinical consultancy working across the UK, Ireland, and the US. A micro and molecular biologist by training, he has worked in life sciences and medical device regulatory affairs for more than 20 years, guiding companies through FDA 510(k), IDE, and PMA pathways as well as CE Mark and Design Dossier approvals.

He has served as an outsourced quality and regulatory department for companies from startup through to acquisition, including Current Health’s exit to Best Buy, and has particular depth in in-vitro diagnostics and pediatric devices. Earlier in his career he helped establish the Scottish Cord Blood Bank and a series of stem cell banks with the Scottish National Blood Transfusion Service. He also lectures on medical device regulation at the University of Strathclyde and the University of Glasgow.

Lindsay appeared on Open Door Salon alongside Christian Espinosa, founder and CEO of Blue Goat Cyber, for a conversation with host Lori Ellis on the three forces that make or break a medtech launch. He drew the line from cybersecurity to patient safety, explained why studies that satisfy the FDA can still fail the payer, and made the case that reimbursement strategy has to enter product design at the concept stage rather than after clearance.