Internationally Accredited Testing Services for Medical Devices, Biomaterials and IVDs

Abstract

The development of medical devices and in vitro diagnostics (IVDs) aims at ensuring patient safety. Hence their safety and efficacy evaluation is critical. These medical devices are made of different kinds of materials like polymers, metals, ceramics, alloys, biodegradable materials, fabric etc., which, when coming in contact with skin, tissue, blood or bone, may cause adverse reactions that endanger human life. These materials and the devices made up of these materials are to be compatible with tissue or blood. If not compatible, the body may reject the material causing adverse reactions. Regulatory authorities like CDSCO in India, US FDA, Therapeutics and Goods Administration in Australia., the Pharmaceutical and Medical Devices Agency in Japan and others enforce strict regulatory compliance to ensure safety and mitigate risks to the end users of medical devices and IVDs.