Sam Lazzara is a Biomedical Engineer and Certified Biomedical Auditor who has served the medical device industry for over 30 years. He is passionate about helping companies work smarter by providing tailored documents, training, and mentoring based on lessons learned during his extensive career. Before becoming a Consultant in 2009, Sam worked in industry for 26 years, establishing customer-focused and regulation-compliant quality systems at companies ranging from start-up to market leader. Sam held Manager, Director and Vice President positions in Quality Assurance, Regulatory Affairs and Operations. Sam’s systems and documents have satisfied dozens of regulatory auditors from the United States FDA, the California Department of Health, and numerous European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. Sam provides state-of-the-art solutions tailored to the needs of each client. He is experienced with a wide range of medium to high risk devices including endovascular, gastrointestinal, hearing, neurosurgical and orthopedic implants; sterile disposables; and combination drug/device products.

Sam received his B.S. in Engineering from Brown University and his M.S. in Engineering from Case Western Reserve University. He is a Senior ASQ Member and a member of AAMI and RAPS.