#United States #Medical Devices #Lisle #ISO 13485 #Ontogen Medtech

Ontogen Medtech Achieves ISO 13485 Certification

Ontogen Medtech, a prominent provider specializing in design and manufacturing services for the medical device sector, proudly announces the achievement of ISO 13485:2016 certification. This prestigious recognition stands as an international benchmark for quality management systems within medical device manufacturing, marking a significant milestone in the company's evolution.

A Commitment to Quality

The attainment of ISO 13485 certification is a testament to Ontogen's unwavering dedication to delivering safe, reliable, and high-caliber medical technologies. According to Mike Corrigan, the President of Ontogen's Manufacturing division, this certification validates the comprehensive quality system the company has established. "It ensures that our partners can trust us with their most critical projects, significantly enhancing the confidence that products developed in collaboration with Ontogen will adhere to global regulatory requirements and the highest quality benchmarks," said Corrigan.

End-to-End Client Support

Now equipped with this certification, Ontogen is strategically positioned to provide holistic support to its clients, spanning from conceptualization and prototyping to pilot production and full-scale contract manufacturing. Their state-of-the-art facility based in Lisle, Illinois, is outfitted with specialized R&D laboratories, dedicated cleanroom environments, and advanced manufacturing equipment. This enables Ontogen to cater not only to established original equipment manufacturers (OEMs) but also to startups and companies in various stages of growth and innovation.

"Medical device companies require more than just design expertise; they seek a collaborative partner who can adapt alongside them and ensure their transition from early development stages to reliable commercial devices. The ISO 13485 certification positions Ontogen to fulfill that role effectively," commented Julie Byars, Principal and Co-founder of Ontogen.

Fostering Innovation in Medtech

The certification serves as a critical milestone, emphasizing Ontogen's role as a collaborative hub for innovations in medical technology. Beyond merely offering contract manufacturing services, the firm also delivers design assistance, regulatory strategy development, commercialization support, and even subleased office spaces for startup clients, aiming to expedite their market entry while alleviating financial burdens.

For clients, achieving ISO 13485 certification translates into:

• - Enhanced regulatory alignment with FDA, EU MDR, and other global requirements.
• - Improved risk management and product safety measures throughout the development lifecycle.
• - Streamlined market entry with compliant manufacturing practices and comprehensive documentation.
• - Scalable production capabilities to support growth from initial pilot stages to full commercial supply.

Impact on Patient Care

The accomplishment of ISO 13485 certification signifies not just an internal achievement but represents a broader industry commitment to improving patient care. With the surging demand for innovative medical technologies, the capacity to offer certified and quality-driven manufacturing services has become increasingly essential for firms introducing new devices to the market.

About Ontogen Medtech

Founded in Lisle, Illinois, Ontogen Medtech is a full-service design and development organization for medical devices, specializing in engineering, regulatory, and manufacturing solutions. Through strategic partnerships with innovators, Ontogen accelerates the journey from idea to market. With the backing of ISO 13485 certification and state-of-the-art facilities, Ontogen provides comprehensive contract manufacturing services supporting both emerging startups and well-established companies in the medical device landscape.

For media inquiries, please reach out to:

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

This strategic move places Ontogen Medtech on the forefront of the medical device industry, ensuring that they remain a pillar of strength and innovation, aiding in the development of technologies that benefit patient care.