ISO13485:2016
Medical device electronics under ISO 13485
Design controls, traceability and documentation discipline are built into our process for ECG systems, IVD equipment and medical-aesthetic devices — not bolted on for the audit.
What we build
Representative products
ECG machine PCBA & box build
Medical aesthetic device ODM
IVD equipment boards
Why MEYATU
What regulated buyers verify first
Quality system
ISO 13485:2016 medical device quality management across the full build
Documentation
Per-unit and per-lot records with real-time test data synchronization
Design support
Joint R&D and NPI pilot runs under the production quality system
Qualifying us? Ask for the audit pack.
Certificates under the MEYATU name, process documentation and reference calls are available during qualification.