As a recognized medical device testing and certification service provider, CSA Group enables manufacturers to demonstrate that their medical products comply with the applicable standards and processes, allowing you to sell your medical devices in markets around the world.

Rely on an internationally recognized company with over 100 years of expertise, knowledge, and reliable services to access healthcare certification experts that help you understand the requirements for existing, new, and emerging medical technologies.

Our global laboratories provide the support medical device manufacturers need at each stage of the product life cycle, including:

• Auditing
• Coexistence testing (per FDA)
• Custom testing, and on-site testing
• Documentation review for risk management process
• EMC and radio testing
• Energy efficiency evaluation
• Usability engineering process review
• Environmental simulation testing
• Global Market Access
• In-depth training, including custom training
• Special Inspection/Field Evaluation
• Technical Information Service - information provided early in the design phase of product development regarding the applicable standards and requirements

ASCA-recognized testing laboratories

Approved by the FDA as part of the Accreditation Scheme for Conformity Assessment (ASCA) Pilot program, CSA Group's laboratories in the U.S.A., Canada, China, Japan, and South Korea can now perform premarket testing for basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory equipment.