TÜV Rheinland Expands Medical Device Testing Accreditation to Include Medical Robotics

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TÜV Rheinland of North America, Inc. has broadened the ISO/IEC 17025:2017 accreditation of its Technology & Innovation Lab in Boxborough, Massachusetts, adding electrical safety testing capabilities for a wider range of medical devices and healthcare technologies.

Accredited by A2LA under Certificate No. 3331.06, the laboratory can serve manufacturers developing products across respiratory care, medical robotics, patient monitoring, diagnostic imaging, home healthcare and other specialized medical applications. The certificate is valid through January 31, 2028.

The expanded medical device testing scope includes capabilities for:

• Respiratory care equipment, including critical-care ventilators, anesthesia workstations, oxygen concentrators, sleep-apnea equipment, home healthcare ventilators, respiratory humidifiers, EMS ventilators and high-flow therapy equipment.
• Robotics, including robotically assisted surgical equipment and medical robots for rehabilitation, assessment, compensation or alleviation.
• Patient monitoring and diagnostic technologies, including electroencephalographs, non-invasive and invasive blood pressure monitoring, multifunction patient monitors, clinical thermometers and pulse oximeters.
• Imaging and radiation-related equipment, including endoscopic equipment, X-ray equipment, computed tomography, radiography, dental X-ray and image-guided radiotherapy equipment.
• Specialized medical equipment, including high-frequency surgical equipment, medical lasers, non-laser light sources, cardiac defibrillators, infant phototherapy equipment, medical suction equipment and ophthalmic instruments.
• Foundational medical-device disciplines, including usability engineering and medical-device software lifecycle processes.

“Our expanded A2LA scope reflects our continued investment in the people, technical expertise and laboratory capabilities needed to support today’s medical device innovators,” said Ryan Braman, Products Regional Stream Coordinator for North and South America, TÜV Rheinland of North America. “By engaging with our experts early in the development process, manufacturers can clarify applicable requirements, address compliance questions, and move toward market readiness with greater confidence.”

In addition to the expanded accreditation scope, TÜV Rheinland has enhanced its Boxborough laboratory through investments in environmental testing resources, shock and vibration testing and a new three-meter EMC chamber that complements its existing 10-meter chamber. These investments are designed to increase capacity and help manufacturers address demanding product development schedules.

Manufacturers can engage TÜV Rheinland’s testing and certification specialists early in the product development process through complimentary design reviews and technical discussions. These services can help identify applicable requirements, clarify relevant standards and address potential compliance issues before final testing.