How long does it take to implement the QMS templates?

With our templates package, most software companies can complete QMS implementation in 6–10 weeks rather than 3–5 months. The templates provide the correct structure and compliant content — you customise with your company details, process specifics, and product information. The optional 2-hour walkthrough session with our expert helps your team understand how to adapt each document correctly.

What format are the templates in?

Templates are delivered in Microsoft Word format (.docx) with professional document control headers, version numbering, and revision history tables already built in. They are structured for easy editing and include implementation guidance notes in comments or a separate instruction document. Once customised, they can be exported to PDF for formal QMS document control.

ISO 13485 QMS Templates for Medical Software — Ready-to-Use Package

Package contents

Everything in the QMS templates package

Nine documentation modules covering the complete ISO 13485 quality management system for medical software — all integrated, cross-referenced, and designed to work together.

QMS Foundation

Quality Manual & Core SOPs

Quality Manual · Quality Policy · Document Control SOP · Record Control SOP · Management Responsibility procedure · Scope of QMS

Design Controls (IEC 62304)

Software Development Lifecycle

Software Development Plan · Architecture Description · Unit/Integration/System Test Protocol · Traceability Matrix · Software Release Checklist · Maintenance Plan

Risk Management (ISO 14971)

Risk Management File

Risk Management Plan · Risk Analysis Worksheet · Hazard Identification Log · Risk Evaluation & Control · Residual Risk Assessment · Risk Management Report

Design & Development

D&D Controls

Design Input Record · Design Output Record · Design Review Minutes · Design Verification Protocol · Design Validation Protocol · Design Transfer Checklist

Post-Market (Annex III)

PMS & Vigilance

PMS Plan · PSUR Template · PMCF Plan Template · Vigilance Reporting SOP · Complaint Handling SOP · Complaint Log Form

Usability (IEC 62366)

Usability Engineering

Use Specification · Usability Test Plan · Formative Evaluation Report Template · Summative Evaluation Report Template · Known Anomalies List

Supplier Controls

Purchasing & Suppliers

Supplier Evaluation SOP · Approved Supplier List · Supplier Qualification Form · Outsourced Process Controls · Critical Component Specification

Quality Events

CAPA & Non-conformance

CAPA SOP · CAPA Form · Non-conformance Report · Root Cause Analysis Worksheet · Effectiveness Check Form · CAPA Register

Audit & Review

Internal Audit & Management Review

Internal Audit Programme · Audit Schedule · Audit Checklist (ISO 13485 full) · Audit Report Template · Management Review Agenda · Management Review Minutes

What makes these templates different

Built for SaMD, not hardware manufacturers — every template uses software development terminology and maps to SDLC activities, not physical production processes
Proven in audits — used by TrustedTraceMed clients that have passed ISO 13485 certification body audits and Notified Body QMS assessments under EU MDR
Current regulatory alignment — updated for ISO 14971:2019, IEC 62304:2015+A1:2015, IEC 62366-1:2015, and 2026 MDCG guidance
Cross-referenced and integrated — documents link to each other correctly. The risk management file references the design control procedure; the CAPA process feeds the management review inputs
Implementation guidance included — each template includes instruction notes explaining what to customise, what to leave as-is, and why each field matters to auditors
Document control headers pre-built — version numbering, review dates, approval fields, and revision history tables already formatted and ready

Package options

Full package (all 9 modules)Most popular

Core QMS only (Modules 1, 4, 7, 8, 9)Early-stage startups

Software-specific add-on (Modules 2, 3, 6)For existing QMS

Expert walkthrough session (2 hrs)Optional add-on

What's not included

EU MDR technical documentation (Annex II/III) for your specific product
Clinical Evaluation Report — product-specific, cannot be templated
Certification body or Notified Body fees

Ready to move faster? Get the templates package and cut your QMS implementation time in half.

Request QMS package →

Which option is right for you

Templates package vs full QMS implementation

Both paths lead to an audit-ready quality management system. The right choice depends on your internal capacity and how much regulatory guidance you need along the way.

Factor	Templates Package	Full QMS Implementation
Best for	Teams with regulatory experience who can adapt templates independently	Teams new to medical device regulations who need guided implementation
Timeline to implementation	6–10 weeks (your team doing the work)	3–6 months (we lead the project)
Expert involvement	Templates + optional 2-hour walkthrough session	Dedicated regulatory consultant throughout
Customisation required	Moderate — you adapt templates to your processes	Minimal — we build processes around your workflows
Audit preparation	Not included (separate engagement)	Included — mock audit + certification support
Cost	Lower (templates fee only)	Higher (full consulting engagement)

Not sure which is right for you? Book a free 30-minute call and we'll give you an honest recommendation based on your team's experience and timeline.

FAQ

QMS templates — common questions

What is included in the ISO 13485 QMS templates package? +

The package includes 50+ controlled documents covering the complete ISO 13485 quality management system for software companies: Quality Manual, complete SOPs and work instructions, IEC 62304 SDLC templates (software development plan, architecture document, V&V protocols, traceability matrix), ISO 14971:2019 risk management file templates, CAPA toolkit, post-market surveillance templates (PMS plan, PSUR, PMCF), internal audit checklists, management review templates, supplier evaluation forms, and IEC 62366 usability engineering documentation. All documents include implementation guidance notes.

How long does it take to implement using the templates? +

With our templates package, most software companies can complete QMS implementation in 6–10 weeks rather than 3–5 months. The templates provide the compliant structure — you customise with your company details, process specifics, and product information. The optional 2-hour walkthrough session helps your team understand how to adapt each document correctly and what auditors look for.

Are the templates up to date for EU MDR and 2026 requirements? +

Yes. All templates are current as of 2026 and aligned with EU MDR 2017/745, ISO 13485:2016, IEC 62304:2015+A1:2015, ISO 14971:2019, IEC 62366-1:2015, and current MDCG guidance documents. The risk management templates use the updated ISO 14971:2019 risk/benefit terminology now expected by Notified Bodies and certification auditors.

Can the templates be used for both ISO 13485 certification and EU MDR CE marking? +

Yes. The QMS templates support both ISO 13485 certification (external certification body audit) and EU MDR conformity assessment under Annex IX (Notified Body QMS assessment). They are not a substitute for the product-specific technical documentation (Annex II/III) needed for CE marking — but they form the compliant QMS foundation that both processes require.

What format are the templates delivered in? +

Templates are delivered in Microsoft Word (.docx) with professional document control headers, version numbering, and revision history tables already formatted. Implementation guidance notes are included within each document. Once customised, documents can be exported to PDF for formal QMS document control and controlled distribution.

What if we need help adapting the templates? +

The optional 2-hour expert walkthrough session covers the most critical adaptation decisions — how to set your software class, how to write compliant intended use statements, how to structure your SDLC evidence, and how to correctly fill in the risk management file. For teams that need more support, we can scope a hybrid engagement where we provide templates plus targeted consulting hours for the most complex sections.

ISO 13485 QMS Templates for Medical Software

Everything in the QMS templates package

Templates package vs full QMS implementation

QMS templates — common questions

After implementing your QMS, what comes next

Cut your QMS implementation time in half.