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Defining Modern Day “Quality Assurance” for Medical Devices

There once was a day when a product might have been deemed “quality checked” if a tiny paper slip fell out of its packaging, saying “Tested by Number 9”. The scrutiny back then, you could argue, was a bit less meticulous than desired. Fast forward to nearly a quarter of the way through the 21st Century. As modern medical technology evolves with leaps and bounds, so does the need for rigorous quality control. Especially when it comes to medical electrical equipment.

Today’s medical device buyers and users, including healthcare professionals and patients, aren’t just concerned with the functionality of a medical device. They are actively invested in understanding its safety measures, as well as chemical composition, sustainability, wireless capabilities, biocompatibility, cybersecurity, and more. There is a much more comprehensive approach to Quality Assurance than ever before. It addresses every facet of your medical device throughout its lifecycle. Savvy medical device manufacturers realize the value of thorough testing before products touch the hands of healthcare professionals or patients.

A modern Quality Assurance program should address the following types of product testing, inspection, and certifications:

Safety Testing and Certification: Ensuring that medical electrical devices are safe for use is paramount. International and regional bodies like IEC, ANSI, and UL set standards for such devices. Countries may also have regulatory bodies to oversee such activities. The most likely place to start is the 60601-1 family of standards but check to ensure which standards are needed for your specific device.

Electromagnetic Compatibility (EMC): It’s crucial that medical electrical devices do not disrupt the functioning of other essential equipment, especially in a clinical setting. EMC testing ensures no unwanted interference occurs. There have been EMC requirements on medical devices for many years and most manufacturers are familiar with the need to comply.

Wireless/Radio Testing and FCC Certification: Many medical devices now incorporate wireless functionality, such as Bluetooth, Wi-Fi, and 4G/5G cellular. Ensuring they meet FCC regulations is vital for safe and effective communications whether inside a professional healthcare environment, a home, or even while out in the community. The advancements of home healthcare equipment are enabling people to be more mobile with their medical devices. The performance must keep up with the patient.


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