Certification of medical devices with focus on usability
April 10, 2019
09:30 - 10:30
_Room Zuse 6, Hall 4.1/7
The usability of medical devices is a decisive factor in enabling patients and users to operate them intuitively and safely. For this reason, the standards DIN EN 62366 or EN 60601-1-6 (for electrically operated medical devices) prescribe a user-centered design process. For the certification of medical devices, manufacturers must be able to prove that the usability was taken into account during the development process, in accordance with the regulatory requirements. With the entry into force of the new regulation 2017/745 on medical devices, this requirement of a user-centered design process, was strengthened and concretized – also in the context of market surveillance after market introduction, to prove basic safety and performance requirements are met.
The workshop provides an overview of the certification process and elaborates on usability in this context. The implementation of a user-centered development process will be explained and illustrated by practical and interactive examples. Products, especially IT-based solutions, are more successful if they are consistently designed to meet user needs. Therefore, the workshop will – in addition to fulfilling regulatory requirements – also focus on how further added value can be generated by methods of user experience design. In the human-centered design process, the interaction between many stakeholders is also taken into account, for example: users (patients/professionals), developers, designers, risk managers, project managers, product owners, etc.
The workshop aims to connect designers with manufacturers and users of medical informatics and is organized by the cluster ICT | Media | Creative Industries in cooperation with the Mittelstand 4.0-Kompetenzzentrum Usability.
Please register online www.healthcapital.de/dmea2019
Note: Room Zuse 6, Hall 4.1/7 is best found via the DMEA App under "Meeting rooms". It is located one level below Hall 4.2 on the east side. Please follow the signs near stage C in Hall 4.2.