Find ISO 14971 Risk Management Consultants

An ISO 14971 consultant (also called a risk management consultant or medical device risk consultant) is a quality systems expert who specializes in helping medical device companies implement ISO 14971 risk management processes. They guide you through risk analysis, risk evaluation, risk control measures, residual risk assessment, and risk management documentation. ISO 14971 consultants work at regulatory consulting firms or as independent risk management advisors.

To find ISO 14971 consultants, start by browsing directories like this one that list risk management consulting firms and individual ISO 14971 consultants. Filter by your device type, risk management scope, and budget. Look for ISO 14971 consultants with experience in your specific device category and recent risk management file development. Many risk management consulting firms offer free consultations to discuss your project needs.

ISO 14971 consulting firms provide comprehensive risk management support for medical device companies. They offer services including ISO 14971 risk management file development, risk analysis, risk evaluation, risk control measures, residual risk assessment, risk management report preparation, and ongoing risk management support. ISO 14971 consulting firms typically have teams of risk management consultants with diverse expertise across different device categories and risk profiles.

ISO 14971 consultants typically charge $150-$300 per hour for solo consultants, while ISO 14971 consulting firms often offer fixed-fee packages ranging from $15k-$50k+ for full risk management file development. ISO 14971 consultants may charge differently based on scope (gap analysis only vs. full risk management file). Factors affecting ISO 14971 consultant pricing include device complexity, number of hazards, and project scope. Many ISO 14971 consulting firms provide transparent pricing during initial consultations.

Look for: clear examples of ISO 14971 risk management files in your device category, recent experience with risk analysis and FMEA/FMECA, transparent pricing and scope, named experts (not just "team"), willingness to put deliverables in writing, and a clear plan for collaboration. Avoid consultants who promise specific regulatory outcomes or can't explain their recent work.

For a complete selection checklist and the top 20 questions to ask: Work with consultants who can provide evaluation frameworks, red flags to watch for, and reference check questions.

An ISO 14971 consultant handles risk management planning, hazard identification, risk analysis, risk evaluation, risk control measures, residual risk assessment, and risk management report preparation. They ensure your risk management file meets ISO 14971:2019 requirements and avoid common pitfalls that lead to certification delays or non-conformances.

Typical ISO 14971 consultant pricing: Solo consultants $15k–$35k (often hourly, $150–$300/hour), Consulting firms $20k–$50k+ (fixed-fee or retainer-based), CRO/Full-service $25k–$60k+. Price drivers include device complexity, number of hazards, scope of risk analysis (single device vs. product family), software requirements, and scope of work (gap analysis only vs. full risk management file).

An ISO 14971 consultant typically handles: risk management planning, hazard identification, risk analysis (FMEA/FMECA), risk evaluation, risk control measures, residual risk assessment, and risk management report preparation. Day-to-day work includes reviewing your device design and manufacturing processes, writing risk management documentation, organizing hazard analysis, preparing risk management files, and managing risk control measures. Some consultants also help with FMEA/FMECA, QMS documentation, and regulatory submissions.

Most ISO 14971 consulting projects range from $15k to $50k+. Solo consultants often charge $150–$300/hour, while firms typically offer fixed-fee or retainer arrangements.

Price drivers include: device complexity, number of hazards, software-heavy devices requiring cybersecurity risk analysis, multiple device variants or product families, scope of risk analysis (single device vs. product family), and scope of work (gap analysis only vs. full risk management file vs. ongoing risk management support).

For detailed pricing breakdowns and negotiation strategies: Work with consultants who can provide typical cost ranges by firm type, pricing model comparisons (fixed fee vs time & materials), and tips for negotiating based on your device stage and internal risk management capacity.

Preparation time typically ranges from 4–8 weeks with a full-service consultant, depending on device complexity, number of hazards, and consultant availability.

Factors that extend timelines: incomplete device documentation, complex risk profiles requiring extensive analysis, multiple device variants or product families, and consultant workload/availability. A comprehensive ISO 14971 risk management file typically requires multiple iterations and reviews.

Watch for: vague answers about device types and risk profiles they've handled, no recent ISO 14971 risk management file examples (only generic "regulatory experience"), unwillingness to put scope and deliverables in writing, promising specific certification outcomes ("we guarantee certification by X date"), and no clear plan for collaboration (who writes what, who owns documents).

Also be cautious of consultants who can't explain their ISO 14971:2019 experience, don't have recent risk management files in your device category, or seem unwilling to discuss how they handle risk analysis and FMEA/FMECA.

No. No consultant can guarantee certification outcomes. Certification bodies make the final decision based on your risk management file's completeness, accuracy, and compliance with ISO 14971:2019 requirements.

A good consultant can significantly improve your chances by: ensuring proper risk analysis, identifying all hazards, structuring risk management documentation clearly, avoiding common risk management pitfalls, and managing certification audit communications effectively. But they cannot guarantee outcomes, and any consultant who promises specific certification dates or outcomes should be avoided.

DIY can work for: simple, low-risk devices with well-documented risk profiles, teams with experienced in-house risk management professionals who've done multiple risk management files, devices with standard risk management requirements, and situations where cost is the only priority and you have significant internal time.

You should hire a consultant when: the device is novel or has complex risk profiles, it's software-heavy or higher-risk, your team has no prior ISO 14971 experience, there's uncertainty about hazard identification or risk analysis, a critical business milestone depends on timely risk management file completion, or you need help with complex risk analysis, FMEA/FMECA, or risk-benefit analysis.

Cruxi is an AI-powered platform that structures your medical device regulatory workflows. It's designed to work alongside consultants, not replace them.

In a hybrid model, Cruxi handles structured documentation and content consistency, while your consultant focuses on risk analysis strategy, hazard identification, and high-level review. This can reduce costs (less consultant time on basic documentation) and speed up preparation (structured workflows are faster than manual document creation). You can work with consultants directly for ISO 14971 risk management file development, or use structured approaches to organize your risk management documentation.

In short: define deliverables per section, review cycles, timelines, and responsibilities on both sides. The Statement of Work (SOW) must explicitly list every task, deliverable, and exclusion. Attach a responsibility matrix as an official exhibit to the contract.

For complete contract guidance: Work with consultants who can provide a sample SOW outline, a checklist of essential clauses (IP ownership, confidentiality, change control, termination), and real-world examples of what to include and exclude.