Summative evaluation of medical devices

A summative evaluation is a crucial step for any medical device seeking approval. This process ensures the product’s safety and effectiveness through user testing, ensuring it meets high standards before market entry.

When performing a summative evaluation, medical device companies must comply with regulatory standards, such as the MDR (Medical Device Regulation) in the EU or FDA guidelines in the USA. These regulations outline several key steps. Here’s how the process works:

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1. Planning and setting objectives

First, an evaluation plan is created, outlining which parts of the product need to be tested. The focus is on safety-critical functions, usage flows, and the product’s usability, and UX, especially in real-world scenarios.

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2. Selecting participants and scenarios

Target users – like doctors, nurses, or patients – are chosen for testing, along with scenarios that reflect realistic, risk-related situations. These tests help verify whether users can operate the product safely and correctly in intended environments.

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3. Conducting the evaluation

Next, the product is tested in a realistic but controlled setting (e.g., a lab) to confirm that it works effectively under real-life conditions. This stage simulates typical usage situations, critical scenarios, and potential error points. The device should be close to its final, market-ready form.

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4. Gathering and analyzing data

During testing, both objective and qualitative data are collected. Objective data focus on issues like how often users encounter errors, while qualitative feedback sheds light on why these errors occur. Together, these insights reveal any design flaws or usability issues.

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5. Reporting results and making improvements

The results are analyzed and thoroughly documented to meet regulatory standards. If any weaknesses are found, the product design is refined, and these adjustments undergo further testing to confirm improvements.

Do you want to prepare your medical device for approval? Then feel free to contact us to learn how we can support you.