Global testing and certification services for medical electrical equipment used in home healthcare

With decades of experience working with the medical industry, CSA Group is well-versed in the latest international medical equipment standards, providing testing, inspection, and certification services to help manufacturers comply with the FDA, Health Canada, EU MDR, CFDA, and other international regulatory body requirements.

Testing and certification services include IECEE (CB Scheme), the FDA ASCA Program, and testing according to the IEC 60601, IEC/ISO 80601 series of medical standards.

Home healthcare devices testing and certification

Our services cover a wide range of home healthcare equipment, including:

  • Ambulatory electrocardiographic systems
  • Automated non-invasive sphygmomanometers
  • Blood Pressure Monitor (NIBP)
  • Cardiac defibrillators
  • Clinical thermometers
  • Electrocardiogram (ECG) Graph/Monitor/Ambulatory
  • Electrocardiographic monitoring equipment
  • Healthcare environment ventilators
  • Holter monitors
  • Home light therapy equipment
  • Medical beds
  • Multifunction patient monitoring equipment
  • Oxygen conserving equipment
  • Oxygen concentrator equipment
  • Pulse oximeter
  • Sleep apnoea breathing therapy equipment
  • Temperature monitoring
  • Transcutaneous partial pressure monitoring equipment
  • Ventilators for ventilator-dependent patients

Global market requirements

No matter where your facilities are located in the world, our local experts can develop a testing plan and certification program that meet your needs and the requirements of your target market.

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.


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

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

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

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Marks & Labels

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

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Value-Added Services

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