Gap Analysis for Your Technical Documentation (EU)
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, compiling it into comprehensive usability engineering files and appropriate human factors documentation. In the process, we identify potential gaps in evidence and documentation, and we organize your usability activities in a structured manner that meets relevant regulatory requirements.
How we help
We will help you conduct a structured assessment of your current technical documentation and use the results to determine specific next steps.
- Gap Analysis conducted by experienced experts
- Assessment of identified gaps and regulatory action required
- Documentation of the results in a structured gap analysis report
- Roadmap with clearly prioritized actions
- Support in implementing identified measures
- Consulting services for preparing technical documentation for conformity assessment
How do we conduct a gap analysis?
01. Gap Analysis – Clarity about the need for action
We analyze your existing technical documentation in light of the relevant requirements of the EU MDR and IVDR. In doing so, we identify specific gaps and highlight which content, supporting documentation, or processes still need to be added or adapted.
02. Roadmap – Prioritizing Next Steps
Based on the analysis, we evaluate the identified gaps and derive specific recommendations for action. You’ll receive a clear roadmap that outlines which steps should be prioritized and in what order they should be implemented.
03. Implementation – Systematically Complete Documentation
Upon request, we can assist you in implementing the prioritized measures outlined in your roadmap. This ensures that any missing content, evidence, or documentation components are systematically added, and your technical documentation is specifically prepared for the conformity assessment.
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
Why Custom Medical?
Experience in the regulated medtech environment: Our team supports medical devices and IVDs throughout various stages of development. This enables us not only to review technical documentation for compliance with formal requirements, but also to contextualize it within the broader framework of the product, its development, and regulatory requirements.
Interdisciplinary Expertise: Technical documentation touches on many areas. At Custom Medical, experts from regulatory affairs, usability, engineering, UX, and software work together. This enables us to thoroughly evaluate interfaces and dependencies.
Practical Recommendations: Our goal is not merely to point out what’s missing. We translate regulatory requirements into concrete, actionable next steps that align with your project, your resources, and your current level of readiness.
Certified processes and secure handling of your data: With our ISO 13485 and ISO 27001 certifications, we operate according to established quality processes and provide a reliable framework for sensitive and regulatory information.
More Than Just a Document Check
Technical documentation does not consist of individual, isolated documents. Much of the content is interrelated – from risk management and usability engineering to verification, validation, and clinical or performance-related evidence.
Thanks to our interdisciplinary experience, we can take these interfaces into account and identify when gaps affect not just a single document, but multiple areas of your technical documentation.
If this reveals a need for further action, we can provide you with direct support as needed. Our teams in Regulatory, Usability, UX, and Software Development will help you address identified gaps in a targeted manner and further develop the necessary evidence or documentation components.
We want to get to know you and your product!
