Quality System Documents & Services

My solo consultancy is geared towards startup medical device companies preparing for quality system lift-off.

The focus of my work is to deliver customized, world-compliant, lean, paperless quality system document sets based on what I have learned in my 35+ year career.

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After day-jobs at 7 firms for 26 years, I transitioned to full-time consulting in 2009. Since then, I have helped over 60 medical device firms set up or renovate their quality systems.

My tailored document sets provide a solid foundation for quality system implementation, whether starting from scratch or renovating an existing system. After delivering the document sets for a fixed price, I provide consulting services for strategic advice, implementation support, regulatory requirements training, internal audits, and independent design reviews.

Caution: I do not have the bandwidth to run my clients’ quality systems. The client needs to appoint managers who use the system to guide their activities, combined with their own experience, common sense and technical/business decision-making skills. As a consultant, I will coach and mentor team members as desired.

Link for detailed description of my quality system documents and services.

Link to Cross-Reference, ISO 13485:2016 vs USA 21 CFR Part 820 vs Lazzara Documents

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. 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 20 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.