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 Pilot 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.