ISO 13485 · FDA QMSR · POWER PLATFORM
Illustrative screen
Every device is a promise to a patient. Your quality system is how you prove it.Quzer keeps that proof in order,so you are ready before the auditor asks.
The product
No separate SaaS silo holding your records hostage. Quzer is built entirely on the Microsoft services your company already licenses — your data stays inside your tenant, under your own governance, from day one.
Front endWhat's inside
Services
Usability engineering and URRA work, from concept through summative validation — built to IEC 62366-1.
Learn more →ISO 14971 risk files that trace from hazard to control to verification, across the full product lifecycle.
Learn more →510(k), EU MDR, and ISO 13485 — regulatory strategy, technical documentation, and QMS build-out.
Learn more →End-to-end state registration for minimum risk pesticides and pesticidal devices across all filing US states.
Learn more →Contact
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