IVD Instructions For Use (IFU) Testing
TE Connectivity’s in-house human factors engineering teams provide comprehensive IVD instructions-for-use (IFU) testing in accordance with FDA recommendations and risk management requirements.
Medical device IFUs are essential to the safe and effective use of medical devices by consumers and medical professionals alike. A good IFU results in an overall improved user experience when using your device.
Instructions for use are a vital aspect of overall risk management efforts. A validated IFU can mitigate risks while effectively delivering important safety information. Early testing with actual users can shed light on potentially confusing aspects of your instructions that could lead to improper device use and the potential for direct or indirect harm. TE has an extensive in-house usability lab that focuses on testing IVD instruments and associated consumables, as well as informing and evaluating the IFU itself.
Core Competencies
- Human Factors Development
- Instructions-for-Use (IFU) Analysis
- and Comprehension Testing
- Point-of-Care (POC) Device Usability
- Analysis
- Usability Testing
- Task Analysis
- In-House Formative and
- Summative/Validation Testing
- Study Participant Recruitment
- Design Feedback
- Readability Studies
- In-Depth Interviews and Focus Groups
- Questionnaires
- Operator/Expert Reviews
- Card Sorting
- Wireframing and Journey Mapping
IFU Testing by Actual Users
The complexity of your device, the physical environment in which it is used, and the experience level of the anticipated user all factor into how usability testing is executed. Whether your device is intended for use by a clinician or a consumer, TE's large and diverse pool of healthcare professionals and everyday consumers provides unfiltered real-world feedback on your device IFU to provide actionable insights that can’t be gleaned from employee reviews. These insights are valuable for ensuring the safe operation of your device and can sometimes lead to device design changes prior to regulatory submission and manufacturing, after which changes become very expensive. Working with TE, our goal is to get your IFU right, first time.
By beginning the IFU assessment process alongside IVD development early in the project, the IFUs further ensure reliable, safe operation and reduce risk. We employ real-world simulations, expert reviews, and readability testing to verify and validate IVD IFU properties. TE ensures that your medical device meets regulatory requirements and the IFUs are validated in compliance with ISO 13485 and ISO 14971.
Areas of Expertise
