Find ISO 13485 Consultants & QMS Experts

An ISO 13485 consultant (also called a QMS consultant or medical device quality consultant) is a quality systems expert who specializes in helping medical device companies implement, maintain, and certify ISO 13485 quality management systems. They guide you through QMS implementation, gap analysis, documentation, internal audits, certification preparation, and ongoing compliance. ISO 13485 consultants work at regulatory consulting firms or as independent quality advisors.

To find ISO 13485 consultants, start by browsing directories like this one that list regulatory consulting firms and individual QMS consultants. Filter by your device type, QMS scope, and budget. Look for ISO 13485 consultants with experience in your specific device category and recent certification success. Many consulting firms offer free consultations to discuss your project needs.

ISO 13485 consulting firms provide comprehensive quality management system support for medical device companies. They offer services including ISO 13485 implementation, gap analysis, QMS documentation, internal audit support, certification preparation, training, and ongoing compliance support. ISO 13485 consulting firms typically have teams of QMS consultants with diverse expertise across different device categories and quality system requirements.

ISO 13485 consultants typically charge $150-$300 per hour for solo consultants, while ISO 13485 consulting firms often offer fixed-fee packages ranging from $15k-$60k+ for full QMS implementation and certification support. ISO 13485 consultants may charge differently based on scope (gap analysis only vs. full implementation). Factors affecting ISO 13485 consultant pricing include QMS complexity, number of facilities, and project scope. Many ISO 13485 consulting firms provide transparent pricing during initial consultations.

Look for: clear examples of ISO 13485 implementations in your industry, recent experience with QMS audits and certifications, 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 certification 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 13485 consultant handles QMS implementation, gap analysis, quality system documentation, internal audit support, certification preparation, training, and ongoing compliance support. They ensure your quality management system meets ISO 13485 requirements and avoid common pitfalls that lead to certification delays or non-conformances.

Typical ISO 13485 consultant pricing: Solo consultants $15k–$40k (often hourly, $150–$300/hour), Consulting firms $25k–$60k+ (fixed-fee or retainer-based), CRO/Full-service $30k–$80k+. Price drivers include QMS complexity, number of facilities, scope of implementation (single site vs. multi-site), software requirements, and scope of work (gap analysis only vs. full implementation).

An ISO 13485 consultant typically handles: QMS gap analysis, quality system documentation, process mapping, internal audit support, certification preparation, training, and ongoing compliance support. Day-to-day work includes reviewing your quality system documentation, conducting gap analysis, organizing evidence for audits, preparing audit reports, and managing certification readiness.

Day-to-day work includes reviewing your quality system documentation, writing QMS procedures, organizing evidence for certification, preparing for audits, and managing certification body communications. Some consultants also help with risk management files, CAPA systems, and supplier controls.

Most ISO 13485 QMS implementation and certification projects range from $20k to $100k+ depending on company size and QMS maturity. Solo consultants often charge $150–$350/hour, while firms typically offer fixed-fee or retainer arrangements.

Price drivers include: company size and number of locations, existing QMS maturity (starting from scratch vs improving existing system), device complexity and risk class, number of processes to document, need for training and internal audit support, and scope of work (gap analysis vs full implementation vs certification 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 QMS stage and internal quality capacity.

ISO 13485 QMS implementation and certification typically ranges from 6–18 months with a full-service consultant, depending on company size, existing QMS maturity, and consultant availability.

Factors that extend timelines: starting from scratch (no existing QMS), large company with multiple locations, complex device portfolio requiring extensive documentation, need for extensive training and change management, multiple audit cycles with certification body, and consultant workload/availability. Certification body audits typically take 1-2 weeks, but preparation and follow-up can extend the timeline.

Watch for: vague answers about QMS implementations and certifications they've completed, no recent ISO 13485 examples (only generic "quality 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 procedures, who owns documents, training approach).

Also be cautious of consultants who can't explain their certification body relationships, don't have recent certifications in your industry or device category, or seem unwilling to discuss how they handle non-conformances and corrective actions.

No. No consultant can guarantee ISO 13485 certification. The certification body (notified body or registrar) makes the final decision based on your QMS implementation, documentation quality, and compliance with ISO 13485 requirements.

A good consultant can significantly improve your chances by: ensuring proper QMS structure and documentation, selecting appropriate processes and procedures, structuring evidence clearly, avoiding common implementation pitfalls, and managing certification body communications effectively. But they cannot guarantee outcomes, and any consultant who promises specific certification dates or outcomes should be avoided.

DIY can work for: small companies with simple device portfolios, teams with experienced in-house quality professionals who've managed ISO certifications before, companies with existing quality systems that just need ISO 13485 alignment, and situations where cost is the only priority and you have significant internal time and expertise.

You should hire a consultant when: starting from scratch with no existing QMS, your team has no prior ISO 13485 experience, the company is large or multi-location, there's uncertainty about QMS structure or requirements, a critical business milestone depends on timely certification, or you need help with complex quality processes, risk management, or certification body negotiations.

Cruxi is an AI-powered platform that structures your regulatory workflow. While we focus on 510(k) submissions, our structured approach to documentation and quality systems can complement ISO 13485 QMS work.

In a hybrid model, your ISO 13485 consultant handles QMS structure, procedure development, training, and certification body management, while you use structured workflows for documentation consistency. This can reduce costs and speed up implementation. You can work with your consultant on QMS implementation, then use structured tools for ongoing documentation maintenance.

In short: define deliverables per QMS process area, 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.