Built for Medical Device Teams That Need More Than Generic Compliance Advice

Our consulting services are designed for businesses that need a quality system that is compliant, usable, scalable, and aligned with real operations. We support startups, growing manufacturers, remediation projects, audit preparation, digital QMS builds, and system optimisation.

What Clients Come to Us For

  • Build a compliant QMS

    Create a structured ISO 13485 system with the right process logic, documentation, and implementation path.

  • Fix a weak system

    Address recurring findings, broken CAPA, document control issues, poor ownership, and weak evidence.

  • Get audit ready

    Prepare for certification, surveillance, supplier, and internal audits with stronger control and clearer readiness.

  • Improve efficiency

    Reduce admin waste, duplicate records, disconnected workflows, and systems that people avoid using.

Who Our ISO Consultancy Services Are Designed For

Our consulting services are best suited to medical device businesses that want clearer systems, stronger controls, better implementation, and a practical route to audit readiness.

  • Startups building from scratch

    You need structure, speed, and a clean route to an audit-ready ISO 13485 system.

  • Growing medical device companies

    You already have processes, but the system is inconsistent, bloated, or difficult to maintain.

  • Teams preparing for certification

    You need implementation support, internal audit coverage, remediation, and readiness guidance.

  • Businesses moving to digital QMS

    You want a controlled system in SharePoint, Microsoft 365, or Google Workspace.

  • Companies dealing with findings

    You need focused support around CAPA, document control, training, supplier controls, or management review.

  • Leadership teams needing support

    You need senior QA/RA input without committing to a full-time internal hire.

Need a broader view first?

You can review our full service offering before exploring consulting packages in detail.

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Core Consulting Services

  • ISO 13485 QMS Framework Development

    Build the structure, document hierarchy, quality manual outline, procedure map, and implementation roadmap.

  • Full ISO 13485 Implementation

    Move from framework to rollout with active support, working sessions, review cycles, and system alignment.

  • Internal Audits

    Remote and on-site audit support covering single processes, partial systems, and full-system internal audits.

  • CAPA and Remediation

    Fix recurring findings, weak root cause work, ineffective closures, and quality system breakdowns.

  • Digital QMS Builds

    Build practical quality systems in SharePoint, Microsoft 365, and Google Workspace.

  • Risk Management Support

    Support with ISO 14971 file structure, hazard analysis logic, and residual risk review.

  • Design Controls Support

    Support with DHF structure, planning, traceability, verification and validation alignment.

  • QMS Optimisation

    Improve system usability, reduce duplication, clarify ownership, and align operations with quality.

ISO 13485 Consulting Packages

Our fixed-fee consulting packages are designed for teams that want clearer scope, better commercial certainty, and outcome-focused support.

Package Best For Includes Starting Price
Framework Development Teams building internally but needing the right structure first QMS architecture, document hierarchy, quality manual outline, procedure map, template set, implementation roadmap From $6,500
Framework + Implementation Teams needing active rollout support Everything above plus implementation support, rollout sessions, review cycles, and working sessions with process owners From $12,500
Full Build + Testing + Audit Readiness Companies preparing for certification or needing near-turnkey support Everything above plus process testing, usability review, internal audit support, CAPA action support, management review support, and audit-readiness pack From $22,000

Final pricing depends on company size, system maturity, number of processes in scope, digital platform, design controls complexity, audit support needs, and timeline pressure.

Google Workspace QMS

Best for smaller teams that want a leaner setup with straightforward administration and lower technical overhead.
Framework builds from $6,500

Full implementation from $12,500

Microsoft 365 QMS

Best for businesses already operating in the Microsoft ecosystem and wanting stronger structure, permissions, and document control.
Framework builds from $7,500

Full implementation from $14,500

SharePoint QMS

Best for businesses wanting a more structured digital QMS environment with stronger control over libraries, metadata, permissions, and controlled workflows.
Framework builds from $9,500

Full implementation from $18,000

2026 Consulting Rates

We keep pricing transparent enough to help serious buyers qualify themselves before entering a scoping discussion.

Advisory Rates

  • Junior Consultant / Analyst — $65/hour
  • Consultant — $95/hour
  • Senior Consultant — $125/hour
  • Senior Principal Consultant — $145/hour

Day Rates

  • Junior Consultant / Analyst — $500/day
  • Consultant — $700/day
  • Senior Consultant — $900/day
  • Senior Principal Consultant — $1,050/day

Audit Pricing

  • Remote internal audit — from $1,250
  • Remote full-system audit — from $4,500
  • On-site audit — from $2,250/day plus travel and accommodation

Retainers

  • Essential support — $1,500/month
  • Growth support — $3,000/month
  • Fractional QA/RA support — $5,500/month
  • Enterprise support — $8,500/month

Minimum engagement: 2 hours for remote advisory support and 1 day for on-site support. Travel and accommodation are billed separately where applicable.

Internal Audit Services

  • Single-Process Remote Audit

    For focused review of one process such as CAPA, document control, training, complaints, purchasing, supplier controls, or risk management.
    From $1,250

  • Multi-Process Remote Audit

    For a more targeted review across linked clauses or selected processes where deeper system visibility is needed.
    From $2,250

  • Full ISO 13485 Internal Audit

    For companies preparing for certification, surveillance, or full readiness review.
    From $4,500

  • On-Site Internal Audit

    For interview-based auditing, physical process review, and deeper on-site system assessment.
    From $2,250/day + travel and accommodation

Related Guidance

Learn more about specific quality system topics through our supporting pages and articles.

ISO 13485 Internal Audit

CAPA ISO 13485

Document Control ISO 13485

ISO 13485 Clause Hub

Specialist Consulting Services

  • ISO 14971 Risk Management Support

    Risk management plan support, hazard analysis structure, risk file logic, and residual risk review.
    From $2,500

  • Design Controls Support

    DHF structure, design planning, inputs, outputs, traceability, V&V support, and change control logic.
    From $4,500

  • Supplier Quality Support

    Supplier controls, qualification structure, supplier audit support, and purchasing controls.
    From $1,500

  • QMS Optimisation Review

    Reduce duplication, simplify workflow, improve usability, and align operations with quality.
    From $3,500

  • CAPA / Findings Response Sprint

    Focused consulting support to respond to findings, strengthen investigations, and improve closure quality.
    From $2,500

  • Audit Readiness Sprint

    A short engagement to tighten evidence, close obvious gaps, and improve readiness before audit.
    From $4,500
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What Sets Our Consultancy Apart

Most ISO consultants stop at templates, clauses, and audit advice. We go further by treating the quality system as an operating system for the business.

That means we do not only ask whether a process exists. We ask whether it works, whether people can use it, whether the controls make sense, and whether the system reduces wasted time instead of adding more admin.

  • Systems-engineering-led QMS design
  • Strong focus on usability, ownership, and control
  • Practical SharePoint, Microsoft 365, and Google Workspace support
  • Better alignment between operations, company systems, and quality systems
  • Strong fit for growing medical device teams that need scalable systems

How Projects Are Scoped

How we start

We begin with a short qualification call to understand your current stage, business model, product scope, certification timeline, platform preference, and immediate pain points.

What affects scope

Typical scope factors include company size, existing QMS maturity, number of processes in scope, design and development inclusion, digital platform choice, audit needs, remediation complexity, and stakeholder availability.

How pricing is finalised

We show starting prices publicly to help serious buyers self-qualify. Final pricing is confirmed after scoping so assumptions, deliverables, and exclusions are clear.

Can we start small?

Yes. Many clients start with a process audit, a scoping workshop, or a focused remediation sprint before moving into a larger implementation project.

Do you work internationally?

Yes. Many consulting engagements can be delivered remotely, including advisory work, digital QMS design, documentation review, and internal audits.

Do you offer SharePoint QMS consulting?

Yes. SharePoint QMS consulting is one of our specialist areas, especially for companies wanting stronger structure, permissions, metadata, and controlled document workflows.

Helpful Articles

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Looking Specifically for SharePoint QMS Help?

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