SESSION 3 (OF 7): What is design documentation and how to implement it
Design and risk management are connected, one follows the other. Even though design and development processes are based on the ISO 13485, we will provide easy-to-use templates to get you started. You will save yourself a lot of time and frustration by maintaining a design log. Design documentation also allows for recording and transference of important information that might be lost when personnel changes.
This workshop contains the following topics:
- Design and development processes
- The design and risk loop
- Design and development documentation
- Maintaining a design and development log
- How to use the design and development template
The purpose of the Workshop Series
This practical workshop series is available for everyone within Twente University that is involved in health technologies. These workshops are relevant for everyone in medical technology, eHealth, in-vitro applications, public health, wellbeing, home care or lifestyle.
This series is practical in nature and tailored to the needs within the University. During the workshops you will learn about regulations, documentation, how to successfully implement your innovation, research on human subjects, research data management and privacy. The workshop are hands-on with easy to use templates so you have everything you need to get started. This documentation is tremendously important if you intend to test your innovation on humans, license it or start a company. The earlier you start building it, the easier it becomes.
All sessions
03 June | Is my innovation a medical device? | |
10 June | Why risk management is important and how to implement it | |
17 June | What is design documentation and now to implement it | |
24 June | Why validation and verification are essential and how to implement them | |
01 July | Increase the chance of making and implementing a 'successful' product | |
08 July | Research on Human Subjects: patients, volunteers, users and public | |
Postponed | Research data management and Privacy |
Organisation
This session is organized by the research program Sustainable Healthcare Technology (SHT), within the TechMed Centre institute. The mission of SHT is to improve the performance, uptake and impact of health technologies developed at the University of Twente that will contribute to making our healthcare future-proof.
Powered by:
