We are proud to announce our obtaining of ISO13485 certification for our digital solutions designed for the healthcare sector.

Envisioning and delivering the best and most user-centric solutions has been part of our never-stopping mission since 1968.
To continue on this path of innovation, our Digital Product Design department recently obtained ISO 13485 international certification for the design of its digital healthcare solutions.

The healthcare realm presents a unique canvas for our design applications. While efforts to boost user experience are integral to any UX design process, our involvement in the medical field has deeper significance. Improving the lives of both patients and professionals who every day perform critical tasks using new digital tools is an opportunity for growth and a serious challenge.
It is maybe the highest expression of what user-centric design means to us.

“Improving the lives of people coping with chronic diseases, enabling them to effortlessly sign documents, save time in their daily routines and receive information with compassion, is a substantial benefit for patients. It offers them the empathic reliability they require. Conversely, healthcare professionals need dependable digital tools to simplify and validate their tasks in a particularly demanding environment. Finally, a well-designed digital tool can significantly simplify the handling of administrative and bureaucratic tasks by ensuring compliance across the board while letting professionals focus on caring and patients.”
explain Andrea Desiato (Digital Product Design Director) and Cristina Paleari (Lead User Experience and Service Designer).

“Safety and quality are not negotiable in the medical devices industry,” says the ISO in fact. “Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery.”

This is why, after several years of collaboration with healthcare sector clients, we decided it was time to obtain specific certification and prove our capability to meet these stringent and necessary standards. The process was fairly complex and not easy. We delved into new regulations to guarantee that our solutions have all the requisites a healthcare supplier must have. We consciously aligned our work process and defined how to document each activity, how to track and control each stage of the design journey in order to satisfy ISO 13485 requirements.

Validating the creation of the digital interface – which is the element we are certified for – helped us to improve our tracking and controlling of potential risks and thereby be sure to deliver the most rigorous digital solutions.

As required by ISO 13485, we have chosen to provide clients with digital products that not only work well but can also protect users from risks that might directly or indirectly affect their health and practices.
Accessibility and readability of final interfaces are of great importance, so interfaces need to be designed specifically for the type of data they will handle. Tests, interviews and analysis of procedures are continuously verified to ensure the reliability of the digital solution, and this is of enormous value when handling medical matters and when design genuinely advocates for users.

About ISO 13485

ISO 13485:2016 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. Such organizations may be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation or servicing of a medical device and the design, development or provision of associated activities.

In Italy, only a handful of design studios are ISO 13485 certified for UX design and we are proud of this rare and important achievement as digital design suppliers to the healthcare sector.

Our accreditation has been assessed by Accredia  a recognized association operating on a non-profit basis under the vigilance of the Ministry of Enterprises and Made in Italy.