Human Factors Engineering
At Beyond Conception, we recognize that successful combination products and medical devices must seamlessly integrate user needs, safety, and regulatory compliance. Our Human Factors Engineering (HFE) service is designed to support pharmaceutical and medical device companies in developing products that are intuitive, safe, and effective for end users. Whether you're navigating complex regulatory landscapes or optimizing user interfaces, our HFE experts provide strategic guidance and hands-on support throughout the product lifecycle.
Our team assists in the creation and refinement of key HFE deliverables, including:
• Use specification and user profiles
• User requirements and justifications
• IFU and labeling
• Task, hazard analyses and use-related risk analyses (URRA)
• HFE study protocols and reports
• HFE summary reports
We ensure your documentation meets global regulatory expectations and reflects best practices in usability engineering.
We facilitate stakeholder engagement by:
• Aligning cross-functional teams on HFE goals and timelines
• Managing your HFE studies led by third-party vendors
• Conducting collaborative workshops and expert reviews sessions
• Managing communication between internal teams and external partners
Our approach fosters a shared understanding of user needs and design decisions, accelerating development and reducing rework.
Navigating the regulatory requirements for combination products and medical devices can be challenging. Our experts provide tailored guidance to help you:
• Interpret and apply relevant standards (e.g., FDA, EMA, IEC 62366, NMPA)
• Prepare for regulatory interactions and submissions
• Strategize for human factors validation and risk mitigation
We stay current with evolving regulations to ensure your product meets all necessary criteria for approval and market success.
