Darren Geaney

Darren Geaney is a Computer System Validation (CSV) specialist and digital validation expert with over 23 years of experience delivering right-sized validation solutions to pharmaceutical and medical device companies. His expertise spans software validation, risk management, and regulatory compliance, with in-depth knowledge of FDA 21 CFR Part 820, 21 CFR Part 11, ISO 62304, and ISO 14971. A certified Lead Auditor, Darren has extensive experience supporting both internal and external audits, including those conducted by the FDA, IMB, TÜV, and BSI.