Novo quality management system receives ISO 13485:2016 certification for medical device development
To better serve customers developing medical devices, Novo will now leverage an ISO 13485:2016 certified quality management system throughout the product development process.
Recognized internationally, the ISO 13485:2016 standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
"We already had a robust quality management system in place," explains Novo Senior Quality Manager Louis-David Parenteau. "We decided to get official certification for ISO 13485:2016 to better serve our medical device clients. Working with a product development company that is ISO 13485:2016 certified is more efficient for them. Having a certified quality management system in place demonstrates that we work according to recognized standards that deliver the best results for our clients."
By providing strategy, design, and engineering services for physical and digital products, Novo (https://www.fromnovo.com/
"At Novo, our design and engineering teams already worked closely together and have developed a range of medical devices that meet international quality requirements,"
Based in Switzerland, the International Organization for Standardization (ISO) is an independent, non-governmental international organization. Through its membership of 164 national standards bodies, ISO brings together experts to develop world-class specifications for products, services and systems to ensure quality, safety and efficiency. For more information about ISO, visit iso.org (https://www.iso.org/
As a strategic product design and innovation company, Novo partners with ambitious leaders to create, revitalize and rethink bold and relevant products from the first stages of product definition to the start of high-volume production. Founded in 2007, Novo offers strategic consulting, industrial design, user experience design, electronic and mechanical engineering, and embedded software and application development services for clients in many sectors including medical, transportation, consumer, and technology. Novo serves clients from two offices in Canada.