Simplexity Product Development Receives ISO 13485:2016 Certification

Simplexity Product Development has been awarded Quality Management System ISO 13485:2016 certification for Product Design and Development related to medical products.

San Diego, CA, November 06, 2019 --( Simplexity Product Development Inc., an engineering design services firm, announced today that it has been awarded Quality Management System ISO 13485:2016 certification for Product Design and Development related to medical products. This ISO certification indicates that the company's quality management system (QMS) meets or exceeds the latest international guidance for medical device product development across all four of its West-Coast offices.

ISO 13485:2016 is an internationally recognized standard for quality management systems, and certification demonstrates an organization’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements for quality.

“This milestone will open new opportunities to develop life-changing products such as medical wearables, patient monitoring devices, endoscopy and catheter-based devices, surgical tools, and home health products,” says Simplexity CEO Dorota Shortell. “While Simplexity has supported medical device clients for years, with this ISO certification our clients will now have the added confidence from knowing that our quality management system has been independently certified to be in compliance with the latest standard."

ISO Certification provides clients confidence that Simplexity prioritizes and is committed to quality in all projects, not only medical device development. Companies in need of high quality product development services will often seek out contract engineering firms with ISO registration in order to save the time and cost of performing additional audits. Implementing a quality system is not about checking a box - it is about increasing quality. The standardized processes, attention to detail, and enforcement of best practices leads to safer and more effective devices and ultimately happier clients and end users.

About Simplexity Product Development

Headquartered in San Diego, CA, with offices in the Bay Area, Seattle, and the Portland area, Simplexity is a product development engineering firm, chosen by leading technology companies to design their next generation products. With a tagline of “simplifying the complex,” Simplexity strives for simplicity in design, reducing product costs and improving the reliability of products. They have a proven phase-gate product development process used to develop hundreds of new products.

While Simplexity offers a suite of services, including mechanical, electrical, and software engineering, their specialty is complete system design, where all disciplines work together to create products which often contain sensors, motors, and electronics. This expertise is applicable for medical, consumer, and commercial products, resulting in solutions that reduce risk and accelerate time-to-market. For more information, visit or contact Simplexity at 858-385-7834 or
Simplexity Product Development
Scott Jarnagin