MDR Ready Software
We develop software applications conform the Medical Device Regulation (MDR) such that they can be used as (part of) class I and class II medical devices.
We develop software applications conform the Medical Device Regulation (MDR) such that they can be used as (part of) class I and class II medical devices.
Whether it is a standalone mobile application that is part of a diagnosis or treatment, or a mobile or cloud software that integrates with a hardware solution for a class II medical device, we are your partner for the development of software with a CE marking.
As of May 2020, medical devices that are placed on the European market must be in compliance with the MDR. With this new regulation, stand-alone software applications are considered a medical device. It is essential to develop such software in compliance with the MDR, using the right harmonized standards. Our organization has the right processes in place to develop your software in such a way that you can easily apply a CE marking and get it approved by a Notified Body.
The most important part of the MDR is having a Quality Management System (QMS) in place. Our software development process involves a QMS that is compliant with the ISO 13485 standard.
We assess and minimize risk conform the ISO 14971 norm, which is required by the MDR.
We develop and manage our software in compliance with EN 62304, which establishes a set of processes for managing the life-cycle of software.
Another important aspect of the MDR is usability. We analyse, specify, develop and evaluate the usability by incorporating usability engineering according to EN 62366.