CORE ServiceS
06. Risk Management & Regulatory Advisory
Transform complex regulatory constraints into a strategic advantage. By integrating human factors into your risk management lifecycle, we ensure your safety arguments are not only compliant but bulletproof under the scrutiny of global health authorities.
DESIGN FOR SAFETY & COMPLIANCE
“We neutralize use-related hazards at the source and defend those mitigations before health authorities, ensuring that safety is not an operator’s effort, but the system’s default behavior.”
KEY OUTPUTS & DELIVERABLES
Use-Related Risk Analysis (URRA)
Comprehensive identification of hazardous situations based on intended use, user groups, and use contexts.
Use Failure Mode & Effects Analysis (uFMEA)
Granular breakdown of perception, cognition, and action failures and their clinical consequences.
Critical Task Identification
Scientifically backed rationales for the tasks that dictate your validation scope.
Risk Control Traceability
A rigorous matrix ensuring every identified risk is countered by a verified risk control.
06.a
Use-Related Risk Analysis
The engine of safety: Transforming risk data into design decisions.
We move beyond static spreadsheets to build dynamic risk models. Using both "top-down" (URRA) and "bottom-up" (uFMEA) approaches, we rigorously identify potential use errors and explicitly link them to risk controls. This ensures your risk file is a living tool that proactively drives engineering and clinical safety.
Ergonomics Factory made sure that all usability and safety-related aspects were systematically assessed and analyzed.
Thomas, Managing Director,
German Research Organization.
KEY OUTPUTS & DELIVERABLES
MDR/FDA Gap Analysis
Comparison of legacy documentation against current international standards.
Retrospective HFE File Creation
Construction of missing technical evidence based on historical performance and post-market data.
Post-Market Clinical Follow-up (PMCF) Analysis
Leveraging real-world evidence to support long-term safety claims.
"Safe and Effective" Justification
Formal expert reports to satisfy Notified Body and FDA requirements for legacy technology.
06.b
Regulatory Remediation
Rescuing legacy products through retrospective compliance.
Regulatory transition (e.g., to EU MDR/IVDR) put established devices at risk due to evolving documentation standards. We support remediation activities (e.g., User Interface of Unknown Provenance (UOUP) process) to retrospectively building HFE files and label updates to validate "safe and effective" history and keep successful products on the market.
We chose Ergonomics Factory because of their technical and regulatory expertise.
Yu-Ting, Senior Human Factors Engineer,
Multinational Pharma Company.
KEY OUTPUTS & DELIVERABLES
HF / UE Summary Report Authoring
High-level synthesis of your entire usability journey and final safety conclusions.
Threshold Analysis & Waiver Justifications
Strategic data packages to support abbreviated pathways for modified or generic devices.
Technical File Construction
Assembly of the HFE section for 510(k), PMA, or EU MDR Technical Documentation.
Submission Narrative Optimization
Refining the language of your file to pre-emptively address common reviewer concerns.
06.c
Filing & Submission Support
The final narrative: Crafting the argument health authorities approve.
Writing an HFE Summary Report is a strategic art. We synthesize years of development data into a clear, compliant narrative that aligns with FDA Guidance and MDR Annex I requirements. We write the documents that the reviewer actually reads to ensure your safety argument is transparent and defensible.
Ergonomics Factory’s proactive, professional, and collaborative approach made for a very positive experience.
Daniela, Design Control Specialist,
Multinational Pharma Company.
KEY OUTPUTS & DELIVERABLES
Pre-Meeting Briefing Packages
Clear, data-driven documents to guide productive discussions with health authorities.
Response to Deficiencies (AI Requests)
Rapid, evidence-based responses to "Additional Information" requests from reviewers.
Scientific Advice Representation
Expert participation in meetings to defend your HFE methodology and conclusions.
Mock Audit & Inspection Support
Preparing your internal teams to present and defend the Usability Engineering File during audits.
06.d
Health Authority Interactions Support
Defending the file: Expert representation when it matters most.
When the FDA or a Notified Body asks the hard questions, we provide the answers. We act as your HFE Expert Witness, supporting you during Pre-Submission meetings and Scientific Advice hearings. We help you prepare briefing packages and craft scientifically sound responses to regulatory deficiencies.
It was refreshing to work with a team that understood both the technical nuances and the regulatory end-game clearly.
Project Manager, Swiss Pharmaceutical Company.
The Strategic Outcome
Regulatory Resilience. Accelerated Clearance.
The ‘Risk Management & Regulatory Advisory’ services provide the final assurance that your technical work survives the scrutiny of the audit. By aligning your risk file with your submission narrative, we minimize the danger of regulatory delays and market recalls. We don’t just help you follow the rules; we help you defend your design to health authorities, ensuring a predictable path to market and a protected lifecycle for your legacy portfolio.
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