Dec 2019 – Adaptive artificial intelligence and deep learning technologies such as SELENA+ differ from other software as a medical device (SaMD) in that they have the unique potential to adapt and optimize performance to continuously improve health care for patients. The International Medical Device Regulators Forum (IMDRF) defines software as a medical device as software intended to be used for medical purpose/s without being part of a hardware medical device.
As an effective assistive tool in the diagnosis of 3 eye diseases, diabetic retinopathy (DR), Glaucoma and Age-Related Macular Degeneration (AMD), SELENA+ is classified as a Class B medical device.
The Good Distribution Practices for Medical Devices (GDPMD) specifies the requirements for a quality management system to be established, implemented and maintained by an establishment in carrying out activities in medical device supply-chain. Our distributor, Nova MSC Berhad recently received its GDPMD certification from Medical Device, Authority of Malaysia upon completing an audit to confirm our compliance with Malaysian medical device regulatory requirements as stipulated in Medical Device Act.
This paves the way for SELENA+ to be deployed in Malaysia.
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