5368 Kuhl Road
Erie, PA 16510
PSN Labs is a leader in biocompatibility and toxicology for the medical industry. Within our ISO/IEC 17025:2015 accredited Testing Lab, PSN Labs has a dedicated team of biocompatibility experts, who are involved at every stage of the development process for medical devices and technology.
Biocompatibility testing (ISO 10993/ ISO 18562) is an important requirement for all medical devices that are patient contacting. Our team stays involved from the very onset of development to ensure the material choices, design, and processing are safe for patients and follow all requirements under the FDA and other regulatory bodies. Whether testing current devices or designing something new, this team will be involved the whole way, including assisting in the FDA 510(k) submission.
There is no one easy answer to toxicology or biocompatibility. Each program is a customized test plan created for each unique device, with test fixtures to isolate the data for just the device components required. Our team of scientists and engineers are trained to isolate confounding variables and provide clear analysis to guide the commercialization of new medical devices. We are passionate about patient safety and ultimately want to ensure that the medical devices and technology on the market are going to increase the quality of life – both in the short and long term – for those who are often the most compromised.
Your Full-Service Engineering Partner
PSN Labs is an Engineering Services firm, specializing in all areas of product development with three distinct but cohesive laboratories: Engineering Lab, Testing Lab, and Processing Lab. Our engineers and scientists have decades of experience within their field and work within as well as across each lab to bring products to market with ease and confidence.
PSN Labs offers comprehensive services with uncompromising quality. Our experience and expertise crosses over a wide range of industries, products, and manufacturing processes, allowing our teams to be a best-in-class choice to help determine and correct the risks associated with medical device manufacturing.