Bitwave UY automates IEC 62304 traceability and test coverage analysis for teams building regulated medical device software. Less spreadsheets, more confidence.
Designed for teams building under IEC 62304 — Class A, B & C
Platform capabilities
Built specifically for the IEC 62304 lifecycle — from requirements capture to test protocol review.
Upload requirements and test protocols in Word, Excel, or Markdown. Our AI extracts structured data and evaluates test coverage against IEC 62304 clauses.
Automatically map every requirement to its associated tests. Instantly surface gaps — uncovered requirements and orphaned tests — in a single exportable view.
Classification-aware analysis for Software Class A, B, and C. Get clause-level compliance scoring and actionable remediation guidance.
How it works
Drop your requirements specification and test protocol files — Word, Excel, or Markdown accepted.
Claude analyzes structure, coverage, and IEC 62304 clause alignment. Results are ready in seconds.
Download your traceability matrix as Excel or HTML. Share with your QA team or attach to your DHF.
Your requirements and test documents are processed in memory and discarded immediately after the analysis completes. We do not write your files to any database or storage system.
Your documents are sent to Anthropic's Claude API solely to produce your analysis. Anthropic does not use API inputs to train its models. Your IP stays your IP.
Data flows encrypted over HTTPS directly from your browser to our server and onward to the API. No third party receives or retains your content at any step.
Pricing
Plans are being finalized. Join the waitlist to be notified at launch.
For individuals and small teams exploring compliance tooling.
For teams actively building IEC 62304-compliant software products.
Custom integrations, SSO, and audit-trail support for regulated environments.
Join teams building IEC 62304-compliant medical device software with confidence. No setup fees. No credit card required.