Registro de Dispositivos Sanitarios
Latest news: COFEPRIS reviewers will accept proof of ISO 13485 quality system certification instead of Establishment Inspection Reports (EIRs) issued by the FDA.
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Medical Devices Class Ir – Transitional Provisions to MDR
It is not easy to follow how and when to apply the new future MDR, a big pressure has been set on the class I reusable medical devices manufacturer to be ready to transition, yes but by when? Well back in July, the rules have changed again but are offering a longer transition period –…
