← Industries we serve
Healthcare & medical devices
We implement ISO 13485 with UDI traceability, ISO 14971 risk management and readiness for COFEPRIS and FDA inspections.
Most relevant standards
- ISO 13485:2016
ISO 13485 — Medical Devices
Quality management system specific to medical devices.
Request a quote - ISO 9001:2015
ISO 9001 — Quality Management System
The foundational quality standard, reinforced with AI for continuous compliance.
Request a quote - ISO/IEC 27001:2022
ISO/IEC 27001 — Information Security
Systematic protection of critical information with risk-based controls.
Request a quote
Tell us about your operation
Book a diagnosis to evaluate which combination of standards fits your business.
Getting certified no longer has to hurt.
Book a free 30-minute diagnosis. We assess your starting point and outline a realistic roadmap.