Sam Lazzara
My blogs
| Industry | Biotech |
|---|---|
| Occupation | Medical Device Consultant |
| Location | United States |
| Introduction | Biomedical Engineer and Certified Auditor with over 30 years experience in medical device quality assurance and regulatory compliance |
| Interests | Sam’s quality management systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 40 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance. |