FathomX works with both governmental and private enterprises to ensure that all products developed are developed in line with the requirements for quality affairs and regulatory affairs for medical devices.
Diagnostics Development Hub
As part of the Innovation Cluster Programme funded by the National Research Foundation (NRF), the Diagnostics Development (DxD) Hub is a national initiative led by A*ccelerate (previously known as ETPL) with the aim to accelerate the transformation of IPs into clinically validated diagnostic devices that are ready for market adoption. They have expertise in regulatory navigation and dossier preparation, ISO13485 product design and development, Design optimisation and verification as well as clinical validation.
FathomX has signed an agreement with DxD Hub to help fast track and accelerate its go to market strategy by tapping onto the regulatory expertise to facilitate clinical trials and maximise resources by designing trials that are effective for regulatory submission, clinical validation as well as health technology assessments. The project is co-funded by DxD Hub and FathomX Pte Ltd.
Quasys is a quality affairs and regulatory affairs consultant that helps medical device companies develop, market and sell products that satisfies the technical, regulatory and quality requirements.
Quasys was engaged as part of a procurement process in the Project Agreement between FathomX and DxD Hub.