Defining Modern Day “Quality Assurance” for Medical Devices

By Derek Silva, Vice President, Marketing, Intertek

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 befo…

Read more
  • 0

Testing and certification of refurbished medical equipment

By L. Matthew Snyder, Sr. Director of Certification at Intertek

Medical electrical equipment such as MRIs, anesthesia machines, surgical equipment, scanning systems, patient monitors and other types of products are a significant investment for any healthcare organization. Refurbished medical equipment, devices that are reconditioned and made comparable to new products, are becoming a realistic option for the industry given their lower costs. In fact, many original equipment manufacturers are increasingly focused on refurbishing equipment, which in turn is pushing growth of the market.

A potentially more budget-friendly approach, refurbished equipment is an appealing prospect for not only healthcare industries but for others that regularly use electrical devices. Given the increased interest in this type of product, the National Electric Code (NEC) has been updated to better ensure the safety and performance of refurbished (or reconditioned) products. Pr…

Read more
  • 0