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REGULATORY ASSURANCE
FOR MEDICAL DEVICES AND IVDs
MDD/MDR, and IVDD/IVDR Regulations
Our consulting services can assist your company in meeting the new regulatory requirements of the EU MDR/IVDR, which may include obtaining a CE Mark through the EU Notified Body. We offer training to help your team understand the impact of the new regulations on your products, guidance on preparing technical documentation, and advanced tools for post-market surveillance and vigilance. Our services also include impact assessment, gap analysis, and support for submitting technical documentation, UDI, PMS, and clinical evidence to the Notified Body.
Medical Devices and IVDs Regulation in Australia (TGA)
We offer consulting services for the medical device industry in Australia. Our team provides technical support with the documentation and requirements for the TGA. We specialize in registration of MD and IVDs, ensuring compliance with the regulatory standards. Contact us today to learn more about our services.