3,000

Organizations Worldwide

Helping manufacturers around the world with testing & certification needs

100+

Years of Experience

Rely on an internationally-recognized organization with over a century of experience

70

Countries

Helping you access 70 country markets for your medical products including North America, China, Japan, and the EU

Specialties

Our extensive technical knowledge of medical electrical equipment and systems, and laboratory & measurement equipment along with our razor-focused knowledge of the compliance requirements in major world markets work together to remove barriers to market access

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) 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.

Services

Sell your innovative medical products from every corner of the world with confidence by working with experts in health care product testing

Featured Icon. Testing

Testing

Transform your innovations into quality products that meet critical requirements with our expert testing services

Featured Icon. Certification

Certification

Launch new products and boost customer confidence in North America and beyond with our global certification solutions.

Featured Icon. Marks & Labels

Marks & Labels

Get the marks you need to access and enter your target markets in North America with confidence.

Featured Icon. Value-Added Services

Value-Added Services

Save time and gain efficiencies with access to our customer portal, online product listings, and more.

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