Cortex News

Cortex Design Announces ISO 13485:2016 Certification

Sam White
Sam White April 07, 2022 • 0 min read

For Cortex Design, the past 16 months have been focused on embracing bold decisions and rapid growth, building and empowering our team, and setting our company and our collaborators up for success by reevaluating the way that we engage; our flexibility, adaptability, and the value that we bring to each partnership. A large part of ensuring this kind of success is dedicating time and resources to build out the appropriate internal processes and frameworks that support our vision for growth. 

In light of that vision, it is with great pride that the Cortex Design team announces our successful ISO 13485:2016 Certification. 

“When I joined Cortex, the mandate was clear,” says James Chalmers, Partner & Chief Executive Officer of Cortex. “The vision was to transform the firm, narrowing the focus on Consumer HealthTech and Medical Devices and scale the business into the US and European markets. Leveraging our ISO 13485 QMS enables us to further de-risk and validate throughout the development, engineering, testing and manufacturing service engagements as we scale. This results in predictable product development outcomes for our clients.”    

Adding ISO 13485:2016 to our existing ISO 9001:2015 QMS is a natural step for the firm. This new operating standard allows our team to build off of the previously implemented processes geared towards ensuring quality and customer success, and enhances focus on patient safety for medical device design and commercialization. 

“Certification of our Quality Management System to ISO 13485:2016 is a very important achievement for Cortex,” says Paul Needler, Regulatory and Quality Manager. “It elevates our current focus on quality by adding a focus on safety. This applies to all processes at Cortex, and ensures compliance to medical device development; from regulatory strategy in Basecamp to Design and Engineering, to Commercialization and all points between. In short, our obligations to compliance are aligned with those of our clients as they bring their medical device to market.”

“I’m excited about this certification because it legitimizes the work we’ve done to get to this point,” says Dylan Horvath, Founder and Chief Product Officer. “Over the past number of years, we’ve dedicated the firm towards excellence in medical device design and this is a culmination of that journey.”

Cortex Design is an award-winning full service product design and manufacturing firm specialized in developing and commercializing innovative medical and consumer products. Established in 1999, the team at Cortex believe that people deserve better experiences. They work with clients to visualize and develop those experiences, and manufacture the solutions. Cortex’s Design for Commercialization™ methodology allows clients to support and/or augment their internal resources to de-risk their product design and launch exceptional products.

© 2022 Cortex Design Inc.