Profile

Sam Lazzara

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Bio

Sam Lazzara is a Biomedical Engineer and Certified Biomedical Auditor with 30+ years medical device quality assurance and regulatory compliance experience. Go to mdqc.blog to view Sam's Blog. 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’s 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 30 firms, leading to third-party certification and government approvals. 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. Areas of Expertise: ISO 13485, FDA 21 CFR Part 820, QMS, Quality Systems, Risk Management.

Year Entered Profession

  • 1980-1984

Current Organization Type

  • Consulting Firm

Highest Degree Earned

  • Masters

Regional Interests

  • Worldwide

Product Interests

  • Combination Products
  • Medical Devices