CMD MedTech
CMD MedTech is a medical device and healthcare product development company dedicated to improving the quality of life for patients and caregivers worldwide. Leveraging systems engineering principles, they develop safe, effective, and compliant healthcare products. They offer a wide range of services including medical device engineering, regulatory consulting, quality systems development, project and program management, and laboratory developed test (LDT) services. As a woman-owned small business, CMD MedTech emphasizes personalized attention, regulatory compliance, and innovative solutions to help clients bring their medical devices to market efficiently.
Industries
Nr. of Employees
small (1-50)
CMD MedTech
Columbus, Ohio, United States, North America
Products
Part 11-compliant electronic document control platform
An electronic document management platform validated to support 21 CFR Part 11 requirements for electronic records and signatures, used for document control, change management, and recordkeeping.
Part 11-compliant electronic document control platform
An electronic document management platform validated to support 21 CFR Part 11 requirements for electronic records and signatures, used for document control, change management, and recordkeeping.
Services
Medical device engineering (systems engineering)
Systems-engineering leadership for device development, including requirements, safety risk management, usability engineering, cybersecurity, and verification/validation oversight.
Medical device regulatory consulting
Regulatory strategy, submission authoring and management (510(k), De Novo, PMA, 513(g), Pre-Sub), and international market support.
Medical device quality systems
QMS development and maintenance services to meet 21 CFR 820 and ISO 13485 requirements, document control, internal audit support, and management review facilitation.
Project and program management
Program and project management services including schedule and budget planning, program risk management, KPI tracking, earned value, and resource coordination.
Laboratory Developed Test (LDT) compliance services
Support for LDT regulatory transition including QMS implementation for labs, test validation and documentation, FDA registration guidance, and electronic records compliance.
Medical device engineering (systems engineering)
Systems-engineering leadership for device development, including requirements, safety risk management, usability engineering, cybersecurity, and verification/validation oversight.
Medical device regulatory consulting
Regulatory strategy, submission authoring and management (510(k), De Novo, PMA, 513(g), Pre-Sub), and international market support.
Medical device quality systems
QMS development and maintenance services to meet 21 CFR 820 and ISO 13485 requirements, document control, internal audit support, and management review facilitation.
Project and program management
Program and project management services including schedule and budget planning, program risk management, KPI tracking, earned value, and resource coordination.
Laboratory Developed Test (LDT) compliance services
Support for LDT regulatory transition including QMS implementation for labs, test validation and documentation, FDA registration guidance, and electronic records compliance.
Expertise Areas
- Regulatory strategy and submissions (FDA and international)
- Quality management systems (ISO 13485, 21 CFR 820, QMSR)
- Medical device systems engineering and requirements management
- Verification and validation planning and execution
Key Technologies
- Model-based systems engineering (MBSE)
- 21 CFR Part 11-compliant electronic document management
- ISO 14971 risk management
- IEC 62304-aligned software development lifecycle