HOME / Testing and Certification / Product Areas / HealthcareHealthcareTesting & certification services to get your medical and laboratory & measurement products into markets efficiently and on time 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 Accredited as a National Certification Body (NCB) through the IECEE CB Scheme and recognized by Authorities Having Jurisdiction (AJHs), we offer testing and certification against leading international standards such as IEC 60601/80601, ISO 8060, and IEC 61010. 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. Medical Electrical Equipment and Systems Laboratory & Measurement ASCA-recognized testing laboratories Home Healthcare Medical Diagnostic Imaging Equipment Medical Robotics Patient Monitoring Equipment Featured Fact Sheet Testing and certification services for electro-medical equipment Medical electrical equipment and systems provide valuable tools that impact patient care. These complex products can contain unique safety and performance issues due to their design. That’s why it’s critical for medical equipment manufacturers to comply with the applicable medical standards. Download the Fact Sheet View All Resources Testing and certification services for electro-medical equipment Download the Fact Sheet Services Take your medical electrical equipment or system, as well as laboratory & measurement equipment, to North American and international markets by working with focused experts in health care product testing & certification and global market access Sell your innovative medical products from every corner of the world with confidence by working with experts in health care product testing Testing Transform your innovations into quality products that meet critical requirements with our expert testing services Certification Launch new products and boost customer confidence in North America and beyond with our global certification solutions. Marks & Labels Get the marks you need to access and enter your target markets in North America with confidence. Value-Added Services Save time and gain efficiencies with access to our customer portal, online product listings, and more.