Ontogen Medtech specializes in comprehensive medical device development, guiding clients through the entire product lifecycle from initial concept to regulatory clearance. Their services are tailored for startups, entrepreneurs, and established companies, emphasizing a collaborative approach that integrates seamlessly with client teams. The company employs robust design control processes and meticulous documentation to ensure that medical devices not only meet user expectations but also comply with stringent regulatory standards, including FDA requirements. Their expertise spans various healthcare sectors, including Class III implants, cardiovascular devices, and in-vitro diagnostics, ensuring a broad capability in addressing diverse medical needs.

The company places a strong emphasis on risk management and usability, adhering to international standards such as ISO 14971 and IEC 62366. Ontogen Medtech conducts thorough product testing and validation to ensure safety and efficacy, employing strategies that include design verification and validation in real-world scenarios. Their commitment to quality is reflected in their extensive experience with regulatory compliance, covering a wide range of standards relevant to medical devices. By offering services such as Design History File creation, software development, and packaging and labeling compliance, Ontogen Medtech positions itself as a trusted partner in the medical device industry, dedicated to transforming innovative ideas into market-ready solutions.

United States

A Chicago-based medical device development firm partnering with entrepreneurs, startups and large organizations worldwide to bring their innovations to life.

Ontogen Medtech

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