Ontogen Medtech Achieves ISO 13485 Certification, Strengthening Contract Manufacturing Capabilities

LISLE, Ill., Oct. 2, 2025 /PRNewswire/ -- Ontogen Medtech, a leading provider of design and manufacturing services for the medical device industry, is proud to announce that it has achieved ISO 13485:2016 certification, the internationally recognized standard for quality management systems in medical device manufacturing. This milestone underscores Ontogen's commitment to delivering safe, reliable, and high-quality medical technologies while expanding its role as a trusted contract manufacturing partner.

ISO 13485 certification demonstrates that Ontogen's quality management system meets rigorous international standards governing the production of medical devices. "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 is now uniquely 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.

"Medical device companies need more than just design expertise," added Julie Byars, Principal & Co-founder of Ontogen. "They need a partner who can scale with them and bridge the gap between early-stage development and reliable commercial devices. ISO 13485 certification equips Ontogen to deliver on that promise."

The certification also highlights Ontogen's role as a collaborative hub for medtech innovation. Beyond contract manufacturing, the company provides design services, regulatory strategy, commercialization support & fulfillment services, and offers subleased office space to startup clients, helping accelerate their path to market while reducing capital burden.

For clients, ISO 13485 certification translates into:

• Stronger regulatory alignment with FDA, EU MDR, and other global requirements.
• Enhanced risk management and product safety throughout the development lifecycle.
• Streamlined path to market with compliant manufacturing and documentation practices.
• Scalable production capacity to support growth from pilot lots to commercial supply.

Ontogen's achievement signals not only an internal milestone but also an industry-wide commitment to advancing patient care. As the demand for innovative medical technologies grows, the ability to provide certified, high-quality manufacturing services will be essential for companies bringing new devices to market.

About Ontogen Medtech
Ontogen Medtech is a full-service medical device design and development firm based in Lisle, Illinois. Specializing in engineering, regulatory, and manufacturing solutions, Ontogen partners with innovators to accelerate the journey from concept to commercialization. With ISO 13485 certification and a state-of-the-art facility, Ontogen offers comprehensive contract manufacturing services to support startups and established companies alike.

Media Contact:
Tyler Panian
Principal, Co-Founder
Ontogen Medtech
630-384-9430
[email protected]

SOURCE Ontogen Medtech LLC