Summative Evaluation
We support you in the planning, implementation, evaluation and documentation of summative studies for your medical products and applications.
Validation of usability and security
The summative evaluation assesses the user-friendliness of a product or application after development and before market launch.
With the summative evaluation, you prove that users can use your medical device safely. In contrast to formative evaluation, which takes place during development, summative evaluation serves to conclusively confirm the overall quality and effectiveness of the product with regard to the usability objectives.
Summative Evaluation according to IEC 62366
The standards IEC/DIN EN 62366, DIN EN 60601-1-6 and the Food and Drug Administration (FDA) require a summative evaluation to be carried out in order to assess the final user-friendliness and safety of a medical device.
In order to carry out realistic and representative user tests, the evaluation of the accompanying documentation is also mandatory: these are usually training measures or training courses on the product and the operating instructions.
UID process of Summative Evaluation
- Preparation of the study: Determination of the evaluation objectives, selection of the test methods and definition of the target groups, development of the study guide and the screener, recruitment & incentivization of virtually all medical and support staff as test participants
- Implementation of the usability test incl.
Provision of test lab rooms in all settings, in particular patient rooms/(intensive care) units or hybrid ORs, audio and video recordings of all test sessions - Systematic evaluation of the collected data to identify usability problems and their impact on the safety and effectiveness of the device.
- Documentation of the study results in accordance with IEC 62366-1 AMD 1:2020-06 and embedding of the “Summative Usability Evaluation Report” in the usability engineering file.
Your advantages with Summative Evaluation:
Optimal UX
Reveals strengths and weaknesses of usability and improves the user experience
Customer centricity
Identifies barriers to use that lead to dissatisfaction among users
Reduction of application risks
Helps to understand usability problems and increase operating safety
Conformity to standards
Meets regulatory requirements according to MDR & FDA
Clean documentation
Provides necessary evidence of compliance with regulatory requirements
High product quality
Design conveys value
Full service for your medical devices
When developing your medical products, benefit from the many years of medical expertise of our YOOme-Expert:innen. YOOme is the largest group of companies for the development of medical products in Europe. It consists of BAYOOCARE, BAYOOMED, Mechatronic, Pulse Product Design and UID – all companies of the BAYOONET Group. The sister companies support manufacturers from the initial idea, through concepts, design, visualization, development, certification, reliable production to post-market surveillance. A YOOme contact person will be available for all your concerns and questions.ing. As part of the YOOme network, we are a partner for placing on the market in more than 50 countries, MDSAP and ISO 13485 certified and support you with post-market surveillance and vigilance.
Yasin Demiraslan
Senior Manager Sales & Business Development
+49 7141 3 77 00 801
