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Compliance doesn't have to be complicated. Our library of ready-to-use compliance documents has been developed by industry experts with over 15 years of experience — so you don't have to start from scratch.

Every document in our collection has been tried, tested, and refined through countless real-world audits, giving you the confidence that what you're downloading is accurate, audit-ready, and built to the standards that matter.

Whether you're preparing for your first certification or keeping your documentation up to date, you'll find everything you need right here.

Browse our full range of templates, policies, and procedures — and get audit-ready today.
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Management Review Procedure

A structured procedure for planning, executing, and documenting QMS management reviews at regular intervals. Ensures ongoing suitability, adequacy, and effectiveness of the Quality Management System, including assessment of improvement opportunities and the need for changes to the Quality Policy and Quality Objectives. Designed to satisfy management review requirements under ISO 13485:2016 and ISO 9001:2015.

Medical Device File Procedure

Establish complete control over your Medical Device File documentation across the full product lifecycle. This procedure covers all device types, classifications, and markets — aligning with ISO 13485:2016, FDA QMSR, and MDSAP. From design and development through to post-market surveillance, it brings QA, Regulatory Affairs, R&D, and Manufacturing into clear alignment, supporting audits, inspections, and regulatory submissions with confidence.

Medical Device Risk Acceptability Policy

A comprehensive Risk Acceptability Policy for medical devices, aligned with ISO 14971 and ISO/TR 24971. Covers the full product lifecycle from design concept to discontinuation, establishing systematic criteria for risk evaluation and benefit-risk analysis. Embeds a clear commitment to patient safety over commercial interests, dynamic risk reassessment, and continuous improvement — going beyond regulatory compliance to define a principled risk management culture.

Periodic Safety Update Report (PSUR) Template

A fully structured Periodic Safety Update Report (PSUR) Template covering every section required under EU MDR/IVDR and UK frameworks — from incident analysis and trend reporting to literature reviews, PMCF/PMPF studies, CAPA, and cybersecurity monitoring for digital devices. Designed to support consistent, audit-ready reporting across every update cycle.

Post Market Surveillance (PMS) Report Template

A comprehensive, fully structured Post-Market Surveillance Report Template covering every section regulators and notified bodies expect — from incident analysis and trend reporting to literature reviews, PMCF/PMPF studies, CAPA, and cybersecurity monitoring for digital devices. Suitable for EU MDR/IVDR and UK frameworks, and fully customisable to your device and organisation.

Post-Market Surveillance Plan

A professionally structured, fully customisable Post-Market Surveillance Plan template for medical device manufacturers. Covers data collection, benefit-risk updates, clinical evaluation, corrective action identification, and trend reporting — designed to keep your devices compliant and your patients safe throughout the product lifecycle.

QMS Supplier Self-Assessment Template

Professional Excel template for evaluating supplier Quality Management Systems against ISO 9001 standards. Features 84 comprehensive questions across 15 quality areas with automatic compliance scoring, detailed guidance, evidence examples, and supplier information capture. Perfect for quality managers and procurement teams conducting supplier audits and pre-qualification assessments. Streamline evaluations with structured questionnaires and instant percentage-based results.

Quality Policy

A concise, authoritative Quality Policy establishing your organisation's commitment to meeting customer requirements, regulatory compliance, and continual improvement. Aligned with ISO 13485:2016 or ISO 9001:2015, it defines Top Management's responsibility for implementation and underpins a structured Quality Management System focused on consistent product quality, enhanced customer satisfaction, and the prevention of nonconformity.

Risk Assessment Template

Professional Risk Assessment Template fully compliant with ISO 14971 & ISO 31000 standards. Includes pre-formatted risk matrices, severity/probability scales, control measure documentation, and traceability frameworks. Save hundreds of hours building compliant risk management systems from scratch. Perfect for medical device manufacturers, quality teams, and organizations seeking ISO certification. Customizable, audit-ready, and built on industry best practices. Everything you need for regulatory-compliant risk assessment.

Risk Management Plan

Define systematic risk management activities, deliverables, and responsibilities with our comprehensive ISO 14971 and ISO 13485-compliant plan template, designed to establish risk criteria, processes, and lifecycle controls for medical devices and regulated products from design through post-market surveillance.

Risk Management Report Template

Document systematic risk management from design through post-market surveillance with our comprehensive ISO 14971:2019-compliant report template, designed to demonstrate regulatory compliance and product safety for ISO 13485 and ISO 27001 certified organisations across the complete product lifecycle.

Supplier Evaluation Form

A structured, audit-ready Supplier Evaluation Form aligned with ISO 13485, ISO 9001, and ISO 27001. Formally assess supplier quality systems, regulatory compliance, operational performance, and information security capability in a single consistent template — suitable for both initial qualification and periodic re-evaluation, and fully customisable to your organisation and supplier categories.
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