August Electronics Achieves ISO 13485 Medical Device Certification

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August Electronics Achieves ISO 13485 Medical Device Certification

Posted by: aeadmin
Category: News

Today, August Electronics is proud to formally announce the launch of its medical device manufacturing services that will support customers across North America from the company headquarters in Calgary, Alberta, Canada. We are now ISO 13485:2016 certified, which is the standard required of a Quality Management System (QMS) for manufacturing electronic medical devices.

ISO 13485:2016 is an internationally recognized quality standard for the design, development, production and sale of medical devices. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

“Well before commencing the certification process, August Electronics already had strong QC practices on our production floor,” said Tanya Korenda, CEO of August Electronics. “As we’ve developed our supply chain and facilities, medical device manufacturing became a natural next step for us. Having manufactured very complex products such as H2S gas monitors, critical to protecting the well-being and safety of humankind, this certification marks a milestone in our growth as a company. All of us at August are excited to continue expanding and diversifying our client base, in addition to helping fulfil the overwhelming need for medical equipment as the COVID-19 pandemic continues to unfold,” she added.

August Electronics’ medical device contract manufacturing services can meet unique requirements across a wide variety of customers. Prior to the company’s medical ISO certification, August Electronics had been working with health and wellness clients, manufacturing devices such as blood pressure and heart rate monitors, diagnostic equipment, personal breathalyzers, air filtering and water purifying devices, personal pain reduction equipment (TENS and PMS), hearing aid devices, as well as personal GPS tracking and wearable sensors.

August Electronics’ state-of-the-art facility with 85,000 square feet of manufacturing space is ready to support all classes of medical device manufacturing. Bringing nearly 30 years of electronics manufacturing experience to every client engagement, August Electronics is a strategic manufacturing partner, guiding clients through the entire product development life cycle.

August Electronics supports customers by providing full access to its vertically integrated services and cross-functional teams. Technical staff members have a broad range of experience comprised of engineering, production and supply chain disciplines within a wide variety of industries to produce everything from single parts to complex mechanisms for critical lifesaving equipment.

August Electronics is currently taking orders for PCB assembly, box build and full turn-key design-build projects for electronic medical devices. For more information on August Electronics and its full list of capabilities click here.