Achieve quick and cost-effective approval for your device. We’ll guide you through the complete development and approval process, including an FDA and IEC 62366-compliant Usability Engineering File.
We’ll help you create a usability file without having to learn complicated regulations and conduct complex usability studies.
Our Services in Detail
Conducting this testing early means that the requirements of intended users can be identified early during development and their implementation can be tested in the next iteration.
Stakeholder Requirements Analysis
During context analysis, we interview or observe users in their natural usage context and environment. We first define the user groups and then develop interview guidance questions for each user group.
User Interface (UI) Design
We design wireframes, create prototypes and design proposals for software and hardware UIs. We offer a variety of services to aid your product design
Evaluations can be performed at any stage of development with design concept sketches, working prototypes, or final products. Evaluations of an early prototype can identify potential design or usability problems early without the higher costs normally associated with usability testing.
In addition to the Johner Institute’s own usability labs, we offer cooperation with partner spaces in countries where we do not operate full-time.
Summative Evaluation / Validation Testing
The goal of summative testing is to provide objective evidence that the user interface can be used safely by the intended users in the intended usage environment. In summative testing, all hazard-related usage scenarios must be tested.
Instructions for Use
We assist you in the process of developing your Instructions for Use (IFU), user manual and training materials. According to the FDA, these materials are considered part of the user interface, and they must be treated with as much care as the device itself.
Benefits of Working with the Verity Compliance
Save Time & Money
- Accelerate your product development by pinpointing opportunities to improve your product, and creating a clear path to market.
- Given our experience handling every type of project, we can precisely estimate the costs and effort necessary to make your project a success.
- Present confidently to regulatory bodies using time-tested methods and documentation.
- Utilize our templates to create documentation faster, including your usability file.
Work with Experts
- Our experts are not only auditors but also members of the standards committees and know exactly what it takes to create an FDA and IEC 62366-1 compliant usability file, ensuring that you avoid embarrassing complaints and costly rectifications.
- Medical device success depends on the extent to which you allow users to complete their tasks quickly, easily, and completely. We guide you through the human factors engineering process to do just that.
- Avoid stress in the audit and approval process, knowing that you are using proven documentation and expertise.
- We handle all aspects of running usability studies, including recruitment and scheduling.
- We offer a 100% satisfaction guarantee. You pay nothing if you are not absolutely satisfied.
Risks of Ignoring Human Factors and Usability
Unfortunately, we observe the following problems again and again:
- No permission to market your products: The FDA and notified bodies are obliged to examine the suitability of your usability file. If the file does not conform to regulations, you will receive it back for revision. This quickly becomes very costly: paying for the auditor, for the revision of the file, and for lost profits if your product is not on the market.
- Failure in marketing by dissatisfied customers: Poor usability leads to dissatisfied customers, unnecessarily high costs for support, and continuous improvements and “tweaks.” Ultimately, customers will choose products that are more usable.
- Damaged patients, compensation: In the worst case, a company doesn’t realize the risks of poor human factors until harm has occurred. This can lead to high indemnity claims and a damaged reputation, and it’s not uncommon: 70% of FDA recalls for software are due to usability issues!
Don’t let it get that far and contact us right away. Together we will develop a human factors engineering process with which you can quickly and cost-effectively obtain a usability file to safely pass audits and approvals.