Usability documentation
Comprehensive usability and human factors documentation clearly demonstrates how the safe and effective use of your medical device or IVD was analyzed, evaluated, and validated as part of the usability or human factors engineering process. It provides a structured foundation for supplying regulatory evidence for technical documentation and regulatory submissions in the EU and the U.S.
We help you classify existing research and development data according to regulatory requirements and compile it into a comprehensive Usability Engineering File or appropriate Human Factors Documentation. In doing so, we identify potential gaps in evidence and documentation and prepare your usability activities in a structured manner to meet the respective regulatory requirements.
How we help
We help you organize your usability and human factors activities, study results, and existing documents in a structured and regulatory-compliant manner – with a clear focus on the evidence required for technical documentation and regulatory submissions in the EU and the U.S.
- Gap Analysis: Identifying Missing Evidence and Next Steps
- Compilation and Documentation of Existing Usability and Human Factors Activities
- Planning Formative Evaluations and Human Factors Validation Tests
- Conducting and overseeing studies in the laboratory and in the field
- Preparation of Usability Engineering Files and Human Factors Reports
How do we handle usability documentation?
01. Gap Analysis – Clarity about the need for action
We analyze existing data, studies, and documents in light of the requirements of your target markets. This allows us to identify specific gaps and determine what evidence, documents, or usability and human factors activities are still needed.
02. Implementation – Targeted Supplementation of Missing Documentation
We adapt existing content and provide support for any necessary additional activities – such as formative evaluations, summative evaluations, and human factors validation.
03. Documentation – Compiling Results in a Traceable Manner
We compile existing and newly obtained results into a Usability Engineering File or appropriate human factors documentation. This creates transparent documentation of your activities, results, decisions, and justifications for both the EU and the U.S.
Certified for excellence
We follow validated processes and maintain a clear focus on quality, traceability, and information security. Our ISO 13485 and ISO 27001 certifications provide a reliable foundation for projects in the regulated environment of medical devices and IVDs.
- ISO 13485
- ISO 27001
Our References for Usability Documentation
Why Custom Medical?
Focus on Medical Devices and IVDs: Our team has many years of experience in the development of complex medical devices and IVDs. This is reflected in clearly structured documents, transparent justifications, and practical evidence.
Regulatory Expertise for the EU and the U.S.: We understand the regulatory requirements of both markets and prepare your usability and human factors documentation accordingly – for technical documentation and regulatory submissions.
One-Stop Usability Services: If evidence is still lacking, we also provide support with the necessary studies – ranging from formative evaluations to summative evaluations or human factors validation, including recruitment, implementation, and documentation of results.
International Support: With offices in Darmstadt and Boston, we support projects in Europe and the U.S. and can conduct studies and prepare documentation close to the respective target markets.
From Identifying Gaps to Product Improvement
Our support doesn’t end with documentation. If the gap analysis shows that additional evidence or adjustments to the product are needed, we can continue working on it right away.
Our teams in usability engineering, UX/UI design, and software development can analyze identified problems, iterate on interfaces and prototypes, and conduct the necessary evaluations.
This allows product improvements, usability testing, and regulatory documentation to be closely integrated – without unnecessary handoffs between different service providers.
Knowledge of Usability and Human Factors Documentation
Expand your knowledge of usability and human factors – from regulatory requirements and missing evidence to human factors reports and structured documentation for the EU and the U.S.
Article
We want to get to know you and your product!
