Electromedical and Electrotherapeutic Apparatus Manufacturing
Size Standard: 1,250 employees
NAICS code 334510 covers establishments primarily engaged in manufacturing electromedical and electrotherapeutic apparatus. This includes MRI equipment, ultrasonic equipment, pacemakers, defibrillators, electrocardiographs, and other electronic medical diagnostic and therapeutic equipment.
This industry represents some of the highest-value medical equipment procurement in government contracting. The Department of Veterans Affairs operates 171 medical centers requiring sophisticated diagnostic imaging equipment including MRI machines, CT scanners, and ultrasound systems. Capital equipment purchases represent significant contract opportunities.
Defense Health Agency (DHA) equips military treatment facilities with advanced medical electronics. Combat casualty care requires portable diagnostic and therapeutic equipment that can deploy with military medical units. Research facilities like Walter Reed National Military Medical Center require cutting-edge medical equipment.
The National Institutes of Health (NIH) and its affiliated research institutions purchase specialized electromedical equipment for medical research. FDA and CDC also procure diagnostic equipment for regulatory testing and disease surveillance.
This is a highly competitive and regulated market requiring substantial investment in research and development, FDA clearances, and quality systems. Large primes dominate major equipment purchases, but small businesses can compete in specialized devices, accessories, parts, and maintenance services.
- Department of Veterans Affairs (VA)
- Defense Health Agency (DHA)
- National Institutes of Health (NIH)
- Food and Drug Administration (FDA)
- Indian Health Service (IHS)
- MRI Equipment for VA Medical Centers
- Ultrasound Systems for Military Hospitals
- Patient Monitoring Equipment
- Cardiac Pacemakers and Defibrillators
- Electrodiagnostic Equipment
These certifications can help you compete for set-aside contracts under NAICS 334510:
What products are included in NAICS 334510?
This code covers MRI machines, CT scanners, ultrasound equipment, pacemakers, defibrillators, electrocardiographs, patient monitors, electroencephalographs, and other electronic medical diagnostic and treatment equipment.
What is the size standard for NAICS 334510?
The SBA size standard for NAICS 334510 is 1,250 employees, which is among the highest manufacturing thresholds. This reflects the capital-intensive nature of medical electronics manufacturing.
What regulatory requirements apply?
FDA 21 CFR Part 820 QSR compliance is mandatory. Most electromedical devices require premarket clearance (510(k)) or approval (PMA). ISO 13485 certification is typically required. Some devices have cybersecurity requirements.
Can small businesses compete in this high-tech industry?
Small businesses compete in specialized devices, accessories, components, maintenance services, and through subcontracting. Set-aside programs help, but major capital equipment is often purchased from large established manufacturers.
What are cybersecurity considerations for medical devices?
FDA guidance requires cybersecurity risk assessment for networked medical devices. Government purchasers increasingly require cybersecurity documentation, software bill of materials, and ongoing vulnerability management.
Businesses below this threshold in average annual receipts qualify as small businesses for set-aside contracts.
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