Nelson Lam, principal consultant at Nelson Lam & Associates, began his practice in
2005 principally focused on serving early-stage medical device companies transitioning
from research & development to commercialization. He brings with him over 17 years
of industry experience in Quality Assurance and Regulatory Affairs working with Class I,
II and II devices. In his last professional position, Nelson served as the VP of Quality,
Regulatory and Clinical Affairs at Abbott Diabetes Care/TheraSense. There, from ground-
up, he established a quality management system and QA/RA organization to support
worldwide product approval and commercialization. Prior to Abbott, Nelson held various
senior positions in Quality and Regulatory in a mix of public and private, mature and start-
up medical device companies. In his current practice, Nelson and his team of seasoned
professionals provide services in the areas of quality management system development,
FDA 510k and PMA submissions, regulatory and clinical strategic planning, compliance
auditing, facilitation of regulatory inspections, project management and certification to
CE Mark & ISO 13485.