Glossary Term
Contract Design and Manufacturing Organization (CDMO)
Definition
A Contract Design and Manufacturing Organization (CDMO) is a third-party entity that provides comprehensive services for designing, developing, and manufacturing medical devices on behalf of MedTech companies. CDMOs offer expertise in areas such as engineering, prototyping, regulatory compliance, and large-scale production, enabling companies to focus on core business activities like innovation and commercialization.
Relevance to the MedTech Industry
CDMOs accelerate the development and manufacturing processes by offering specialized resources, reducing time-to-market, and ensuring compliance with regulatory standards. They are critical for small to mid-sized companies lacking in-house capabilities and for larger companies seeking to optimize efficiency and scalability.
Additional Information & Related Terms
Original Equipment Manufacturer (OEM) Similar in scope but focuses primarily on manufacturing rather than design.
ISO 13485 Governs quality management systems for medical device manufacturing, which CDMOs must comply with.
Design Controls A key area where CDMOs contribute during device development.
Post-Market Surveillance CDMOs may support data collection and analysis for real-world device performance.