A medical device CDMO (Contract Development and Manufacturing Organization) is a company that provides comprehensive product development and manufacturing services to medical device companies, specially start-ups. They essentially serve as outsourced partners that handle some or all aspects of bringing a medical device to market.
Key services typically offered by medical device CDMOs include:
Design and engineering support
Prototype development
Regulatory consulting and compliance management
Materials selection and sourcing
Manufacturing process development
Quality management systems implementation
Testing and validation
Scale-up production
Packaging and sterilization
Supply chain management
Medical device companies (especially startups and small-to-medium enterprises) often work with CDMOs to:
Access specialized expertise and equipment without large capital investments
Navigate complex regulatory pathways more efficiently
Accelerate time-to-market
Scale production capacity flexibly
Focus on core competencies while outsourcing specialized development and manufacturing tasks
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