Sara Adams

Sara Adams has spent over 15 years helping MedTech companies prepare for FDA inspections and build strong quality systems. Her expertise spans startups and established organizations, where she has led teams through high-stakes audits, simplified compliance, and improved operations. Sara is skilled in Quality System Inspection Techniques (QSIT) and the practical application of 21 CFR Part 820. She focuses on making complex processes simple and actionable, ensuring teams are confident and prepared for inspections. Known for her clear, no-nonsense approach, Sara has trained professionals at all levels to navigate audits with ease. Using her ISO 13485 Lead Auditor certification, Sara combines technical know-how with a passion for quality. When she’s not demystifying regulations, she enjoys mentoring and helping the next generation of MedTech professionals succeed.