Certifications

Scope: The design, manufacture, and distribution, of Software as a Medical Device (SaMD) in the aid to assessment of cognitive function and diagnosis of cognitive impairment as seen in Mild Cognitive Impairment, Alzheimer’s Disease and dementia.

By aligning with this rigorous, globally recognized quality management system, we are:

Reliability at Every Stage: From research and design through manufacturing and support, our processes meet strict medical device standards.

Consistent Excellence: Our certification validates that we follow best practices to consistently produce top-tier products and services.

A Trusted Partnership: When you choose GT Diagnostics, you gain a partner who meets international benchmarks for delivering safe, effective solutions.

Count on our certification to give you confidence that your projects are in capable, compliant hands every step of the way.

Scope: Authorised Representative and import; distribution (including transportation); and documentation (including traceability of medical devices) of medical software.

By aligning with the stringent standards of GDPMD, we ensure:

Reliability at Every Step: From sourcing and storage to handling and distribution, our processes comply with strict medical device requirements.

Consistent Quality: Our GDPMD certification confirms that we follow recognised best practices to deliver products that meet safety and performance expectations.

A Trusted Partnership: Choosing GT Diagnostics means working with a partner who upholds internationally accepted standards for the responsible distribution of medical devices.

You can rely on our certification to give you full confidence that your medical devices are managed with care, compliance, and integrity throughout the entire supply chain.