Verification and Validation (V&V) are among the most resource-intensive processes in medical device and pharmaceutical development, especially under ISO 13485, 21 CFR Part 820, and MDR frameworks.

Drawing on my experience I help companies design automated, traceable documentation systems that connect design input requirements, risk analyses, and test protocols through reproducible pipelines.

Using Quarto, R, and structured templates, I develop integrated workflows where updates in one document — such as a design input or hazard analysis — automatically propagate to test plans, reports, and validation summaries. This ensures real-time consistency, reduces manual errors, and supports efficient audit readiness.

🚀 Key Features

• Automated generation of test plans, protocols, and reports from structured design inputs
• Live linkage between risk management (ISO 14971) and verification matrices
• Reproducible document pipelines built in Quarto, R Markdown, or Python
• Full traceability and version control for regulatory submissions
• Streamlined collaboration across QA, R&D, and Regulatory Affairs

This service empowers healthcare, biotech, and medical device companies to ensure compliance while accelerating documentation cycles — turning regulatory processes into robust, data-driven workflows.