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Our team works diligently to ensure your testing and certification experience is a transparent one — going above and beyond to proactively inform you through each stage of your project.
As a full-service provider, CSA Group provides holistic product testing, inspection, and certification services for medical electrical equipment, medical electrical systems, and laboratory equipment, helping you demonstrate compliance with the IEC 60601 and IEC 61010 family of standards and launch products in global markets.
Access a wealth of technical expertise to help you navigate your medical device certification project.
To certify that medical devices are safe for patients and medical staff, manufacturers must demonstrate that products comply with the IEC 60601 family of medical device standards, which is the foundational requirement for safety and essential performance. Compliance with other standards, such as IEC 62304 for medical device software and cybersecurity, may apply depending on the type of device.
CSA Group is an accredited and nationally recognized medical device testing laboratory. From ambulatory electrocardiographic systems, medical beds, and Positron Emission Tomography (PET) machine certification to medical robotics, we provide medical device certification services for a vast array of medical equipment.
Through the medical device certification program, our global laboratories can provide the support medical device manufacturers may need to demonstrate compliance with medical device regulatory requirements at each stage of the product lifecycle, including:
Approved by the FDA as part of the Accreditation Scheme for the Conformity Assessment (ASCA) Pilot program, CSA Group's laboratories in the US, Canada, China, Japan, and South Korea perform premarket testing for basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory equipment.
Internationally recognized company with over 100 years of experience.
Technical expertise that lets you go to market with confidence.
Widely recognized by numerous North American and international organizations.
A broad range of testing and certification services for a variety of product categories.