End-to-End Risk Management

Effective risk management is more than a regulatory requirement — it’s the foundation of product safety, performance, and long-term market trust. At Heurnova Consulting, we deliver comprehensive, end-to-end risk management solutions that integrate seamlessly with every stage of your product lifecycle, from concept through post-market surveillance.

Our process begins with establishing a structured risk management framework in alignment with ISO 14971, ISO/TR 24971, and EU MDR expectations. We support your team through hazard identification, risk analysis, and evaluation using tools such as Preliminary Hazard Analysis (PHA), FMEA (Design, Process, and Use-Related), and Fault Tree Analysis (FTA). Each step is meticulously documented and traceable, ensuring a defensible link between design inputs, verification activities, and residual risk justification.

Beyond documentation, we focus on building a living risk management system — one that evolves alongside design changes, regulatory shifts, and field performance data. Our services extend through benefit-risk analysis, risk control verification, and post-market risk file maintenance, ensuring continuous compliance and product resilience.

Risk Management Framework Development

Do you need a structured, compliant framework that defines how risk is identified, evaluated, controlled, and documented throughout the product lifecycle? We develop a tailored risk management framework aligned to ISO 14971 and your operational environment, ensuring your organization has a clear and repeatable approach to evaluating and controlling product risk.

This includes defining roles, decision criteria, documentation structure, and review processes. You’ll gain a strong foundation for consistent, defendable, and audit-ready risk practices across all product lines. This framework serves as the foundation for consistent application across products and lifecycle stages.

Deliverables we can provide include, but are not limited to:

Define risk policy, roles, and responsibilities.
Establish acceptance criteria for residual risk.
Ensure integration with QMS (CAPA, Design Control, and PMS).
Map documentation flow: Risk Plan → Risk Analysis → Risk Report.
Maintain traceability between hazards, mitigations, and design outputs.

Risk Planning & Documentation Setup

Not sure which documents, templates, or controls are needed to properly organize your risk management records? We establish your risk management file structure, including procedures, risk plans, risk evaluations, control logs, and review checkpoints.

Our approach ensures your documentation is complete, navigable, and aligned with regulatory submission expectations. This provides long-term maintainability and reduces audit exposure caused by unclear or fragmented records.

Deliverables we can provide include, but are not limited to:

Define scope and lifecycle stages covered by the plan.
Establish review intervals and approval workflows.
Document linkage to design and manufacturing phases.
Include version control and change management provisions.

Hazard Identification & Analysis

Do you need support identifying all relevant hazards, use errors, and environmental conditions associated with your product? We facilitate structured hazard identification workshops and analyses, evaluating normal use, reasonably foreseeable misuse, and system-level impacts.

Our methods ensure thorough coverage of functional, mechanical, electrical, biological, software, and usability-related hazards. This results in a complete and well-supported hazard inventory, forming the backbone of a strong risk evaluation process.

Deliverables we can provide include, but are not limited to:

Identify foreseeable misuse and user error conditions.
Use data from complaints, CAPA, and post-market feedback for updates.
Distinguish between product, process, and use-related hazards.
Quantify severity, occurrence, and detectability using defined scales.
Maintain clear traceability from hazard → cause → mitigation.

FMEA (Failure Modes and Effects Analysis)

Would you like to better understand where your design or process is most vulnerable — and how to prioritize improvements? We lead Product, Design, and Process FMEAs to systematically evaluate failure modes, their causes, and potential effects on safety and performance.

We ensure ranking criteria and scoring reflect real-world severity and detectability considerations. You’ll receive a clear set of prioritized risks and targeted mitigation actions that directly strengthen product reliability and safety.

Deliverables we can provide include, but are not limited to:

Define rating scales for severity, occurrence, and detection (S/O/D).
Calculate Risk Priority Numbers (RPN) or use alternative ranking methods.
Identify and document recommended control actions.
Recalculate RPNs or risk levels after mitigation.
Ensure consistency between DFMEA, PFMEA, and the overall Risk File.

Risk Control & Mitigation Implementation

Need guidance selecting effective controls and demonstrating that they meaningfully reduce risk? We evaluate mitigation strategies — including design changes, protective measures, labeling, and training — and document their rationale and effectiveness. Controls are aligned to hazard severity and benefit-risk balance, ensuring they are appropriate, defensible, and verifiable. This provides confidence that risk reductions are real, measurable, and regulatory-compliant.

Deliverables we can provide include, but are not limited to:

Apply controls in the correct order: design → protective measures → labeling.
Verify effectiveness of controls using validation and verification data.
Ensure mitigations do not introduce new or greater risks.
Document residual risk justification and user information.
Maintain linkage to design verification/validation evidence.

Residual Risk Evaluation & Benefit-Risk Analysis

How do you determine whether remaining risks are acceptable — and how do you justify that decision? We perform structured residual risk evaluations and benefit-risk assessments based on clinical relevance, performance requirements, and user needs.

The outcome is a documented rationale that demonstrates your product provides net positive value while maintaining safety. This ensures regulatory alignment and supports product release decisions with clarity and confidence.

Deliverables we can provide include, but are not limited to:

Use quantitative or qualitative comparison of risk vs. clinical benefit.
Ensure justification is documented per ISO 14971 §7.
Aggregate individual risks for overall residual risk acceptability.
Include traceable rationale approved by competent authorities.
Communicate residual risks through labeling, training, or IFUs.

Risk Report & Lifecycle Review

Do you need your risk records consolidated into a final, audit-ready risk report? We compile and finalize your Risk Management Report summarizing risk activities, mitigations, evidence of control effectiveness, and residual risk acceptance decisions.

The report integrates seamlessly into your DHF or Technical File and supports both regulatory submissions and internal release approvals. This ensures lifecycle traceability and long-term maintainability.

Deliverables we can provide include, but are not limited to:

Confirm the RMR includes references to all current design versions.
Verify risk acceptance aligns with policy and management review input.
Document periodic updates during design changes and post-market phases.
Retain all risk records under document control with revision history.
Cross-reference RMR to clinical evaluation and PMS reports.

Post-Market Surveillance & Risk Update Integration

How will you adapt your risk controls based on complaints, field performance, or regulatory updates? We establish post-market monitoring criteria, trending methods, and feedback-loop integration to ensure real-world performance continuously informs ongoing risk management. This creates a dynamic and proactive system of surveillance that promotes sustained product safety and regulatory alignment throughout the product lifecycle.

Deliverables we can provide include, but are not limited to:

Feed post-market data (complaints, vigilance, PSURs) into risk files.
Trend recurring failure modes and evaluate need for design change.
Verify CAPA outcomes are reflected in updated risk documentation.
Schedule periodic reviews to confirm continued effectiveness of mitigations.
Maintain risk file alignment with CER and technical documentation.

Training & Continuous Improvement

Would you like your internal teams to confidently participate in risk evaluation and mitigation discussions We provide targeted training and cross-functional facilitation to develop internal competency in risk identification, scoring, justification, and documentation. This empowers teams to maintain and evolve the risk management system over time, strengthening organizational maturity and resilience.

Deliverables we can provide include, but are not limited to:

Train cross-functional teams on FMEA, fault tree, and hazard analysis methods.
Maintain training records with competence evaluation.
Promote risk-based thinking during design reviews and audits.
Assist in integrating FMEAs as living documents into CAPA, NCR, and Complaints systems.
Update risk templates and processes based on lessons learned.

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