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)
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
Systems-engineering leadership for device development, including requirements, safety risk management, usability engineering, cybersecurity, and verification/validation oversight.
Regulatory strategy, submission authoring and management (510(k), De Novo, PMA, 513(g), Pre-Sub), and international market support.
QMS development and maintenance services to meet 21 CFR 820 and ISO 13485 requirements, document control, internal audit support, and management review facilitation.
Program and project management services including schedule and budget planning, program risk management, KPI tracking, earned value, and resource coordination.
Support for LDT regulatory transition including QMS implementation for labs, test validation and documentation, FDA registration guidance, and electronic records compliance.
Systems-engineering leadership for device development, including requirements, safety risk management, usability engineering, cybersecurity, and verification/validation oversight.
Regulatory strategy, submission authoring and management (510(k), De Novo, PMA, 513(g), Pre-Sub), and international market support.
QMS development and maintenance services to meet 21 CFR 820 and ISO 13485 requirements, document control, internal audit support, and management review facilitation.
Program and project management services including schedule and budget planning, program risk management, KPI tracking, earned value, and resource coordination.
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
News & Updates
Changes to FDA recognized consensus standards for medical devices, including new versions and the end of acceptance for older versions, impacting device development and compliance.
Updated guidance issued by the FDA in June 2022 for electromagnetic compatibility (EMC) of medical devices, detailing testing, risk assessment, and compliance considerations.
Overview of the FDA’s phased enforcement of laboratory developed tests (LDTs) regulation beginning May 6, 2025, including each phase's focus and requirements.
Discussion on the implications of FDA’s new LDT regulation enforcement and how laboratories can turn compliance into operational improvements.
Clarification on the limitations of 510(k) exemption for certain medical devices, emphasizing the importance of verifying exemption status and understanding restrictions.
Changes to FDA recognized consensus standards for medical devices, including new versions and the end of acceptance for older versions, impacting device development and compliance.
Updated guidance issued by the FDA in June 2022 for electromagnetic compatibility (EMC) of medical devices, detailing testing, risk assessment, and compliance considerations.
Overview of the FDA’s phased enforcement of laboratory developed tests (LDTs) regulation beginning May 6, 2025, including each phase's focus and requirements.
Discussion on the implications of FDA’s new LDT regulation enforcement and how laboratories can turn compliance into operational improvements.
Clarification on the limitations of 510(k) exemption for certain medical devices, emphasizing the importance of verifying exemption status and understanding restrictions.