Veriqa is an AI agent that writes test protocols, generates validation reports, and tracks regulatory compliance for medical device companies. Autonomously.
QA engineers spend months writing the same test protocols, copying regulatory requirements into spreadsheets, and formatting validation reports that look identical to last quarter's. Meanwhile, the FDA keeps adding requirements and global regulations keep diverging.
Four capabilities that replace weeks of manual QA work.
Feed it device specifications. Get IQ/OQ/PQ test protocols back, formatted to your company's standards, with traceability matrices built in.
Automatically cross-references your documentation against FDA 21 CFR Part 820, ISO 13485, EU MDR, and IEC 62304. Flags gaps before you submit.
Generates complete validation reports from test data and execution records. Consistent formatting, proper signatures blocks, ready for audit.
Watches for regulatory updates, standard revisions, and guidance changes. Alerts your team when existing validations need review.
Veriqa understands the regulatory landscape your products live in.
Veriqa exists so QA engineers can focus on what matters: making sure devices are safe. Not formatting documents.