The usability of medical devices is a critical factor for patient safety, efficiency, and user satisfaction. Inadequate usability can lead to use errors—with potentially serious consequences. The standard EN 62366-1 (applicable to all medical devices; EN 60601-1-6 for medical electrical equipment) defines the usability engineering process as a mandatory part of the technical documentation. Since many incidents involving medical device are linked to poor usability, the usability of medical devices places high demands on user interfaces. EN 62366-1 defines a structured process for usability optimization that is closely integrated with risk management. This process includes the analysis, specification, development, as well as verification and validation of usability.Our experienced usability team supports you in creating a comprehensive Usability Engineering File (UEF) and integrating it seamlessly into your product development process. Whether your product is already on the market or still in development – we help you meet regulatory requirements and improve the usability of your medical devices.Contact us for an initial, no-obligation introduction!
‘Suitable for use’:
How much it takes until a product meets this requirement!
How much it takes until a product meets this requirement!
Our services for standards-compliant usability
- Usability Studies (Summative Evaluations) & Validation Studies – Planning and execution in collaboration with experienced partners
- Creation of the Usability Engineering File (UEF) – For new products, existing devices, and legacy devices (according to Annex C of EN 62366-1)
- Optimization of User Interfaces – Preventing use errors early in the development phase
- Integration into Risk Management – Aligned with the risk management file in accordance with EN ISO 14971
- Training & Consulting – Practical implementation of EN 62366-1 for your team
Let’s explore how we can support your team – we look forward to meeting you!
Usability studies: Understanding user interaction with the product
Whether in a laboratory, simulation, or real-world application – usability studies reveal how a product is used, what issues arise, and how design adjustments can improve safety and efficiency. Particularly in combination with post-market surveillance (PMS), they provide valuable insights for product optimization.Field usability studies are particularly useful for uncovering user errors. However, due to the small sample size, low-frequency errors often remain undetected. This is why the use of additional techniques, such as risk analysis, is essential.Together with our partners, we assist you in planning and designing your usability study. From your technical documentation, we extract the requirements for your usability study and integrate the results back into the technical documentation.Sounds helpful? Contact us for an initial, no-obligation consultation!
TIP
In practice, it is worth examining whether usability study activities can be linked with the PMS activities of Clinical Affairs.
Usability engineering file: Proof of usability[
The Usability Engineering File (UEF) documents the entire usability process and is an integral part of the technical documentation.Requirements vary depending on the product status:
Our usability team will guide you through the entire process and ensure that your documentation meets regulatory requirements. Let’s optimize your usability strategy together!
- New Development: From the analysis of use specifications to formative evaluations and validation.
- Existing Products: Assessment of incidents and error analyses as proof of usability. The usability engineering file itself is structured and organized in the same way as for a new development.
- Legacy Device, i.e., a device that was on the market before the standard was published and that may not have undergone a complete usability engineering process during its original development: A retrospective application of EN 62366-1, Annex C, is required to demonstrate usability.
Our usability team will guide you through the entire process and ensure that your documentation meets regulatory requirements. Let’s optimize your usability strategy together!
Our services for your usability engineering file
- Creation of the Usability Engineering File (UEF),
- Creation of the Usability Engineering File (UEF) according to Annex C,
- Alignment of content with the risk management file,
- Organization and integration of usability experts for conducting customer surveys and validation studies,
- Workshops, training, and consulting on the practical implementation of the requirements of EN 62366-1.
Usability activities make a product tangible. They provide the manufacturer with direct feedback and show whether the product design truly is truly aligned with the user and intended use.The better a product is adapted to the context of use, target audience, and environment, the more efficiently and safely it can be used. That’s why usability should be an integral part of product development from the very beginning –not only to save time and costs throughout the product lifecycle but also to sustainably increase the product’s acceptance and safety
.
Dr. Sandra Neidhöfer, Usability Expert at Metecon.
