Human Factors Engineering at Freyr
Nearly 70% of medical devices companies struggle with meeting safety standards and regulatory compliance due to inadequate usability testing.
At Freyr Solutions, we specialize in transforming medical device usability testing to ensure your devices not only meet but exceed safety standards, enhance user satisfaction, and achieve seamless regulatory compliance with precision and expertise.
Benefits of Usability Testing
Discover how Freyr Solutions' FDA-recommended usability testing can enhance your medical devices
- Validate device efficiency and effectiveness.
- Ensure seamless integration into user routines.
- Prioritize safety through rigorous testing protocols.
- Reduce user errors.
- Facilitate regulatory approval.
Experience seamless approval process for Human Factors compliance
Preparing Your Device for Usability Testing
At Freyr Solutions, we ensure your medical device meets stringent safety standards, enhances user satisfaction, and achieves regulatory compliance through our proven approach
Human Factors Documentation involves creating a detailed plan and analysis framework to ensure your medical device meets usability standards and regulatory requirements. Human Factors documentation is essential for regulatory submissions to agencies like the FDA (Food and Drug Administration) or the European Medicines Agency (EMA). This includes:
- Usability Plan: A detailed strategy outlining the objectives, methodologies, and timeline for the usability testing process. It serves as a roadmap for all subsequent usability activities.
- Gap Analysis: Identifying areas for improvement by comparing your device/existing document against international standards and respective regulatory requirements.
- Use Specification Creation: A document that defines how the device is intended to be used in various environments and by different user groups, ensuring all use cases are considered.
- Identification of Known Use-Related Issues: Documenting and analysis of historical usability problems, which helps in anticipating and addressing potential issues.
- Task Analysis: Breaking down the task's users will perform with the device to identify potential usability challenges.
- Hazard and Use-Related Risk Analysis (URRA): Identifying and assessing risks associated with the use of the device, focusing on potential hazards that could arise during typical use.
- Summary HFE/UE Report or Usability Engineering File (UEF): Comprehensive documentation that encapsulates the usability engineering process and outcomes, serving as evidence of compliance with usability standards and regulatory requirements.
Formative evaluation in medical device usability testing is an iterative process aimed at improving the design and functionality of the device by identifying and addressing usability issues during the development phase. The primary goal is to enhance the user experience and ensure the device is safe, effective, and user-friendly before it reaches the final stages of development or market release.
- Creation of Formative evaluation Protocol: Creating detailed plans for conducting formative usability tests, including objectives, methods, participant selection, and data collection strategies
- Data Analysis & Reporting: Systematically gathering data during usability tests and analyzing it to uncover usability issues and areas for improvement.
- Compiling Formative Report: Providing actionable recommendations based on test findings to enhance device usability and user experience
Methods of Formative Evaluation
- Expert Review
- Cognitive Walkthrough
- Comparative Analysis
- Competitive Analysis
- Cognitive & Perceptual Capability Analysis
- Environmental Assessment
- Anthropometric Assessment
Summative Evaluations Services are critical in the final stages of medical device development. These services focus on validating the device's usability and performance under real-world conditions to ensure it meets both user needs and regulatory standards. The key components of summative evaluations include:
- Creation of Summative Test Protocol: Detailed protocols are developed to outline the procedures, objectives, and methodologies for final-stage usability testing.
- Participant Recruitment: Identifying and recruiting participants who represent the target user population. This involves selecting users with varying levels of experience, different backgrounds, and diverse demographics to ensure comprehensive testing.
- Test Facilities & Environment Simulation: Creating environments that closely mimic the actual conditions in which the device will be used. This includes replicating clinical settings, home environments, or other relevant contexts to evaluate device performance under realistic conditions.
- Conduct Summative Testing: Performing comprehensive usability tests with recruited participants. This involves observing users as they interact with the device, noting any difficulties, errors, or inefficiencies, and gathering qualitative and quantitative data on device performance.
- Comprehensive Data Analysis & Reporting: Gathering detailed data from usability testing sessions, including user feedback, error rates, task completion times, and other relevant metrics and analyzing test results and compiling detailed reports.
- Residual Risk Analysis: Evaluating and mitigating any remaining risks after testing to ensure that the device is safe and reliable for end-users.
Expert Consultation and Support
Count on Freyr Solutions for expert guidance throughout your device lifecycle:
- Avoid regulatory scrutiny with our comprehensive support.
- Elevate validation testing to ensure optimal safety and usability.
- Benefit from insights and strategies tailored to your specific needs.
Celebrating Customers Success
Medical Devices
Registration and LR Support
Global
Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.
Arie Henkin
VP - Quality and Regulatory, Australia -based, Leading SaMD Company
Medical Devices
Swiss Rep Services
Japan and Switzerland
I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.
Darren Mansell
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company
Medical Devices
Registration and AR Services
Malaysia and Indonesia
Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.
