How We Can Support Your Business

  • Build a QMS

    ISO 13485 system design and implementation

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  • Fix a QMS

    CAPA, audit findings, remediation support

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  • Get Audit Ready

    Internal audits and readiness support

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  • Move to Digital QMS

    SharePoint, M365, Google Workspace systems

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ISO 13485 Consulting That Focuses on Real Systems

Most ISO 13485 consulting focuses on documentation and audit checklists. That is necessary, but it is not enough on its own.

We design and support quality systems that are compliant, usable, and aligned with how your business actually operates. That includes system structure, process ownership, digital platforms, and implementation support.

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Choose Your Fastest Route

  • Buy Templates

    Shop practical ISO 13485 and ISO 14971 toolkits, starter packs, and execution systems.

    View All Templates 

  • Use the Clause Hub

    Start with clause-level guidance and move directly into products and supporting content.

    Open Clause Hub 

  • Get Free Resources

    Use free templates and checklists to start gap assessment, document control, CAPA, and DHF work.

    Get Free Resources 

  • Hire ISO Cloud Consulting

    Use service support for QMS setup, digital QMS builds, and implementation help.

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Consulting Pricing Overview

We provide both fixed-fee project delivery and advisory-based consulting. Pricing is shown to help serious buyers understand typical engagement levels.

Advisory consulting from $95/hour
Internal audits from $1,250
ISO 13485 QMS builds from $6,500
Full implementation projects from $12,500+

CAPA System Not Working?

If your CAPA process is producing repeat issues, weak root cause analysis, or audit findings, the problem is not the form—it is the system behind it.

Most companies struggle with:

  • superficial root cause conclusions
  • corrective actions that do not address real failure modes
  • poor linkage between CAPA, complaints, and risk
  • ineffective closure decisions

These issues are one of the most common reasons ISO 13485 audits fail.

Fix your CAPA System

We Design Systems, Not Just Documents

Our approach is built around systems engineering principles. That means your quality system is designed to be used, not avoided.

We focus on:

  • usability
  • process clarity
  • ownership
  • integration with operations
  • reducing admin burden
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Built Around How Medical Device Teams Actually Search

Use the Clause Hub to move from educational searches into the right templates, training kits, and implementation support faster.

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ISO 13485 Audit Readiness Assessment

Medical Device Audit Readiness Score: Assess Your ISO 13485 QMS Before an Audit Exposes the Gaps

This audit readiness diagnostic is designed for medical device companies that need a serious view of how prepared their quality management system is for certification, surveillance, supplier, internal or remediation audits. Answer the questions below to assess your current position across document control, management review, internal audit, CAPA, risk management, supplier control, validation, traceability and operational evidence. You will receive an instant score, a readiness band, your weakest areas, and the next actions most likely to reduce audit risk.

What this tool checks

Strong audits do not fail only because procedures are missing. They fail because systems are not aligned to real practice, records are incomplete, responsibilities are blurred, risk files are disconnected from design and operations, CAPAs close weakly, supplier controls are shallow, or teams cannot retrieve objective evidence quickly under pressure.

Document Control Management Review Internal Audit CAPA Risk Management Supplier Control Validation Traceability

Who this is for

  • Medical device startups building a first compliant QMS
  • QA/RA managers preparing for certification or surveillance audits
  • Teams inheriting a weak or poorly implemented system
  • Companies dealing with repeat findings, CAPA delays, or audit remediation
  • Businesses moving into SharePoint, digital QMS, or structured documentation environments

Complete the diagnostic

1. Is your quality manual and top-level QMS structure aligned to how the business actually operates?

Check whether the written system reflects real roles, process flow, outsourced activities, and regulatory context.

2. Are controlled procedures, forms, templates and records current, approved, versioned and available at point of use?

This is where many systems fail: obsolete forms, uncontrolled copies, poor revision discipline, weak document access.

3. Does management review include meaningful inputs, actions, accountability and follow-through?

Not just minutes. Real review inputs, outputs, decisions, metrics, resourcing and evidence of closure.

4. Are quality objectives, KPIs and ownership clear enough to show QMS control rather than administration only?

Auditors look for whether management can demonstrate direction, monitoring and action, not just paperwork.

5. Is your internal audit programme risk-based, scheduled, independent and capable of identifying meaningful findings?

A weak internal audit programme usually shows up before external audit does.

6. Can your audit reports clearly link findings to evidence, classification, root cause expectations and follow-up?

Generic audit reporting reduces the commercial value of internal audit and leaves remediation weak.

7. Does your CAPA system show strong problem definition, investigation depth, true root cause and verified effectiveness?

One of the most common reasons CAPA systems fail is superficial closure with no proof the problem is actually controlled.

8. Are nonconformances, complaints, audit findings, supplier issues and trend data feeding CAPA consistently?

A mature system shows connected quality data, not isolated records.

9. Is your risk management process current, traceable and connected to design, change control, complaints and post-market inputs?

Risk management should live across the product lifecycle, not sit as a static file. This is central to ISO 14971 discipline.

10. Can you clearly show hazard identification, risk evaluation, controls, residual risk and post-production review?

Good risk files are structured, reviewable and evidence-based, not just copied templates.

11. Are supplier qualification, monitoring and re-evaluation supported by risk-based evidence and clear controls?

Supplier approval based on a once-off checklist is usually not enough for audit resilience.

12. Where process validation, sterilization, software, environmental control or inspection controls are required, are they validated and maintained?

This includes evidence that validated states are controlled and re-reviewed after change.

13. Is traceability adequate for your device class, process requirements, records, release controls and complaint linkage?

Traceability is often present in theory but weak in record retrieval, lot history or linkage to quality events.

14. Can you demonstrate competence, training effectiveness and role clarity for people performing quality-critical activities?

Training matrices alone are rarely enough. Auditors look for competence, not attendance only.

15. If an auditor asked for objective evidence today, could your team retrieve the right records quickly and confidently?

Audit readiness is not only about having documents. It is about evidence retrieval, consistency and control under pressure.

16. Do you have a controlled plan for audit preparation, remediation, ownership and closure if significant gaps are identified?

Many teams only act once the audit is close. Mature teams build a remediation path early.

Answer every question to receive a full diagnostic.
Overall Score
0%
Band

Your audit readiness result

Documentation & Control

0%

Quality manual, procedures, records, change and document control.

Leadership & Oversight

0%

Management review, objectives, direction and accountability.

Audit, CAPA & Risk

0%

Internal audit, CAPA robustness and risk management discipline.

Operations & Evidence

0%

Supplier control, validation, traceability, competence and retrieval.

Highest-priority gaps to address

    What a focused remediation project should cover

      Request a focused gap review

      Submit your details and receive a practical next-step review based on your score profile. This is best suited to teams preparing for certification, surveillance, supplier, remediation or internal audit programme improvement.

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      Why Teams Buy From ISO Cloud Consulting

      Built specifically for medical device quality and regulatory work.
      Practical toolkits, not generic template fluff.
      Designed to support audits, evidence creation, training, and implementation.
      Strong fit for startups and lean teams that need speed without losing structure.

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      Risk Management File Rejected?

      If your ISO 14971 risk management file has been rejected, flagged in audit, or challenged during submission, the issue is rarely just documentation.

      Most failures come from weak hazard logic, missing traceability, inconsistent risk evaluation, or poor residual risk justification.

      We fix risk files properly—so they stand up to auditors, notified bodies, and regulatory review.

      Fix Your Risk File

      Shop by Compliance Need

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      What You Can Buy or Build With ISOCloud

      • ISO 13485 Starter Systems

        Starter packs and essential toolkits for teams building the system from the ground up.

        Shop starter packs 

      • Training Kits & Competence

        Ready-to-run training products for CAPA, complaints, design controls, PMS, risk, and audits.

        View Training Kits 

      • Document Control & Records

        Document control, records, training, and QMS core structure for stronger system control.

        Explore DOcument Control 

      • Risk Management & ISO 14971

        Risk systems, training, and linked workflows for medical device manufacturers.

        View Risk Products 

      Need More Than Templates?

      Use ISO Cloud Consulting for QMS implementation support, digital QMS builds, and practical documentation help when downloadable files alone are not enough. This is where you route teams that are serious but time-poor.

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      Learn Before You Buy

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      Frequently Asked Questions

      Are these generic templates?

      No. These are positioned and structured for medical device quality and regulatory work, especially ISO 13485 and linked compliance execution.

      Do you only sell templates?

      No. ISO Cloud Consulting also offers service-based support for QMS implementation and digital QMS builds.

      Is this suitable for startups?

      Yes. The product mix and homepage structure are designed to work especially well for startups, lean SMEs, and growing regulatory teams that need to build faster without losing control. The templates, training kits, and implementation routes help smaller teams create structure, evidence, and audit readiness without needing a large internal quality department.

      Where should I start if I am not ready to buy?

      Start with the free resources collection or the ISO 13485 clause hub, then move into the relevant toolkit or service once your gap is clearer.