Medical devices are increasingly capable of performing complex functions and processes to assist in the diagnosis, prevention, monitoring, or alleviation of distinct conditions. Regardless of their functions, however, it is universally important to demonstrate the biocompatibility of all materials utilized in the device’s manufacture. This is true of low-risk devices like handheld surgical instruments and high-risk devices like pacemakers and deep-brain stimulators. The Food and Drug Administration (FDA) classifies medical devices from Class 1 – 3, each of which must be subjected to robust toxicology screening to comply with manufacturing quality control (QC) standards.
Demonstrating the biocompatibility of medical devices is fundamental for meeting QC standards for Class 1 medical devices, particularly those manufactured via novel methods or with proprietary materials. At Jordi Labs, we approach medical device toxicology screening from a holistic point of view. First, we determine if your device is of substantial equivalence to an existing product before utilizing a range of advanced analytical tools for analytical testing.
Jordi Labs is also prepared to assist in demonstration of the substantial equivalence of your devices to prepare Class 1 – 3 medical devices for the fulfillment of a 510(k) review. We can also assist in the preparation of premarket approval (PMA) applications where the FDA will ascertain the safety of your device. This will hinge on the biocompatibility of your device and will demand sufficient toxicology screening to achieve device clearance.
At Jordi Labs, we utilize the most advanced analytical tools to evaluate the potential toxicity of your medical devices from the ground-up. We can examine all inbound raw materials and conduct post-processing QC to detect and identify toxic elements that may have propagated into the product through the manufacturing environment.
Toxicology Screening with Jordi Labs
Jordi Labs specializes in the performance of toxicology screening for a broad range of manufacturing sectors, including the medical device industry. We routinely support manufacturers of Class 1 – 3 medical devices to achieve regulatory compliance for market-ready products. Contact us for more details.