Ontogen Medtech, a provider of design and manufacturing services for the medical device industry, said it has achieved ISO 13485:2016 certification, a standard for quality management systems in medical device manufacturing.
"Achieving ISO 13485 certification is a pivotal step in Ontogen's growth," said Mike Corrigan, President of Ontogen's Manufacturing division. "It validates the robust quality system we have built and ensures that our partners can trust us with their most important projects. For our clients, this means greater confidence that products developed and manufactured with Ontogen will meet global regulatory expectations and the highest quality standards."
With this certification, Ontogen said it is now positioned to provide end-to-end support for its clients, from concept and prototyping to pilot production and full-scale contract manufacturing. The company's Lisle, Illinois facility features specialized R&D laboratories, dedicated cleanroom space, and advanced manufacturing equipment designed to serve startups, growth-stage innovators, and established OEMs alike.
