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Overview

Make sure that your medical electrical equipment and systems are ready for the global market with comprehensive testing, inspection, and certification services.

Did you know?

  • With $156 billion* in annual sales, the U.S. has the largest medical device market in the world and accounts for 40 percent of the global marketplace.
  • The medical device industry employs people in all 50 states and is responsible for almost 2 million jobs in the U.S.
  • * Source: http://www.selectusa.gov/medical-technology-industry-united-states

New medical electrical equipment and systems are contributing to more effective disease prevention, diagnosis, and treatment. Today’s rapid pace of healthcare technology innovation means even more lives can be enhanced or saved tomorrow. But certifying the safety, reliability, portability, and security of these new technologies presents significant challenges.

Navigating the path to compliance is critical to business success and global market access for manufacturers of medical devices as well as medical electrical, laboratory, test, and measurement equipment. This path includes testing, inspection, and certification – including electromagnetic compatibility (EMC) and cybersecurity. CSA Group has the technical expertise and global reach required to address complex regulatory requirements and help speed new medical products to market.

Major reasons CSA Group is your best choice for meeting the challenge of testing and certifying today’s medical electrical equipment and systems:
  1. Customer focus: Our experienced staff is committed to working within your deadlines – early in your product development process – to deliver responsive and reliable service and help prevent delays in getting your product to market
  2. Global reach: No matter where in the world your facilities are located, our local experts will develop a medical device testing and certification program that meets your needs
  3. Deep expertise: CSA Group offers unparalleled technical expertise in both new and emerging medical technologies, including biomedical and electrical, helping to ensure technical consistency across organizations
  4. Future minded: We respond to more than just today’s medical device testing and certification needs – we anticipate tomorrow’s
  5. Rapid market penetration: As a global leader healthcare safety testing and certification, CSA Group can help you rapidly get your medical devices into markets around the world

Products Certified

We provide standards, testing, and certification for a wide array of medical electrical equipment and systems.

Medical electrical equipment and systems offer invaluable benefits but can also present great health and privacy risks through flawed design or malfunction. The experts at CSA Group can be trusted to identify
and help resolve risks so you can safely and confidently go to market.

CT Scanners

CSA Group can help assure that your CT Scanners meet regional and global standards for safety so that doctors can base their treatments on clear and valid data.

Incubators

CSA Group has the deep expertise and experience to test and certify incubators that help protect human life at its most vulnerable.

Cardiac defibrillators

Trust CSA Group to test and certify the safe critical functioning of cardiac defibrillators that can save lives across the world.

Operating tables

Take advantage of our industry-leading expertise to have your operating tables certified to meet demanding standards for safety and sanitation.

Lung ventilators

Poor design and production of lung ventilators can contribute to infection transmission and negative or even fatal health outcomes. CSA group has the microelectronics and biotechnology expertise to certify complex products that sustain life at its most fragile.

Shop Standards

Access North American and global markets by meeting the right standards for your medical electrical equipment and systems.

CSA group has a wide range of global experience in developing standards for medical electrical equipment and systems. The standards we test against include IEC 60601 and IEC 61010.

Services

Get your medical electrical equipment and systems tested, inspected, and certified for safety, cybersecurity, and global market access

Testing

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

Certifications

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

Marks & Labels

Get the marks you need for local and global North American market access and enter your target market with confidence.

Value-Added Services

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

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