Certified in activities regarding: Design, development of Medical Devices and lvD Medical Devices. Risk Management and Usability Engineering activities.
We celebrate our certification to ISO 13485: 2016, the international standard for medical devices. It is a long-awaited update from the well-established ISO 13485: 2003.
We have been working on implementing ISO 13485: 2016 in a timely manner and have obtained our certification well before the transitional period’s deadline. Technolution is currently some of the only consultants in Denmark, who have an ISO 13485:2016 certification for the development of medical devices.
Our QA team has strived for a lean system at an appropriate level, ensuring that we are in compliance, and at the same time, that the system is easy to use in the development process.
“It is great to achieve an ISO 13485: 2016 certification and at the same time update our system, so it is, even more, business-oriented and therefore entrenched throughout the organization”
Achieving certification to the new standard is a manifestation of our ongoing focus on improving our management system, and at the same time meeting our customers’ expectations, of structure and quality in a highly regulated medical sector. With the new standard, we and the industry are even closer to our vision of working with a risk-based approach to product development of medical devices.
“Technolution has been ISO 13485 certified for several years, but the 2016 version has given us incentive to a thorough review of our system. We started this process early on, to have the time, to create a new structure for our system. The result is, that our new system is even better tailored to our customers’ needs, efficient to use and acts as a framework for a good development process while focusing on all business processes.” Marianne Lind, Quality Manager, Technolution
We look forward to taking the system into use for our clients.