Glossary Term
Contract Manufacturing Organization
Definition
A Contract Manufacturing Organization (CMO) is a third-party company that specializes in the production of medical devices or components on behalf of MedTech companies. CMOs handle manufacturing processes such as assembly, testing, packaging, and distribution, enabling MedTech companies to focus on product development, marketing, and innovation.
Relevance to the MedTech Industry
CMOs provide cost-effective and scalable manufacturing solutions, allowing MedTech companies to reduce operational complexity and overhead. They are critical for accelerating time-to-market, ensuring product quality, and maintaining compliance with regulatory standards.
Additional Information & Related Terms
Contract Design and Manufacturing Organization (CDMO) A broader entity that also offers design and development services in addition to manufacturing.
ISO 13485 The quality management system standard for medical device manufacturing, applicable to CMOs.
Original Equipment Manufacturer (OEM) Focuses on producing components or devices sold under another company’s brand.
Quality Assurance (QA) A critical aspect of CMO operations to ensure device safety and efficacy.