Verification and Validation (V&V) are among the most time-consuming parts of medical device and pharmaceutical development, especially under ISO 13485, 21 CFR Part 820, and MDR.
I help build automated, traceable documentation systems that tie design inputs, risk analyses, and test protocols together in reproducible pipelines.
With Quarto, R, and structured templates, I build workflows where a change in one place, say a design input or a hazard analysis, carries through to test plans, reports, and validation summaries right away. That keeps the documents in sync, cuts manual errors, and gets you ready for audit.
What it includes
- Automated generation of test plans, protocols, and reports from structured design inputs
- Direct linkage between risk management (ISO 14971) and verification matrices
- Reproducible document pipelines in Quarto, R Markdown, or Python
- Full traceability and version control for regulatory submissions
- Easier collaboration across QA, R&D, and Regulatory Affairs
Healthcare, biotech, and medical device companies can keep compliance and move through the documentation faster at the same time.