ReguLogix Shop

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.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

1 Hour Consultation

Book a tailored 1-hour session with a seasoned medical devices compliance consultant from ReguLogix Consulting Ltd, helping you confidently navigate regulatory strategy, quality systems, and market entry requirements.

30 Minute Consultation

Book a tailored 30-minute with a seasoned medical devices compliance consultant from ReguLogix Consulting Ltd, helping you confidently navigate regulatory strategy, quality systems, and market entry requirements.

Anti-Counterfiet Policy

Protect your organization's integrity, brand reputation, and supply chain security with our comprehensive Anti-Counterfeit Policy Document, fully aligned with ISO 27001:2022 information security management standards.

Assets Management Procedure

Take control of your organisation's assets from acquisition to disposal with our comprehensive Asset Management Procedure, fully aligned with modern information security and corporate governance standards.

Audit Procedure

Standardise and strengthen your organisation's audit function with our comprehensive Audit Management Procedure, fully aligned with internal control, risk management, and regulatory compliance best practices.

Audit Report Form

Document and communicate audit findings with clarity and consistency using our professionally structured Audit Report Form, designed to support rigorous, actionable reporting across all internal and external audit activities.

CAPA Form

Log, investigate, and close out non-conformances with confidence using our structured CAPA Form, designed to support rigorous root cause analysis, corrective action tracking, and verified resolution across all areas of your organisation.

Change Mangement Form

Evaluate, authorise, and track changes with control and accountability using our ISO-compliant Change Management Form, designed to meet ISO 13485, ISO 27001, and ISO 9001 governance and audit requirements across all organisational systems and processes.

Code of Conduct International Data Transfers

Ensure compliant, secure cross-border data transfers with our binding Code of Conduct for International Data Transfers, fully aligned with GDPR, UK GDPR, and global data protection standards to safeguard data subject rights worldwide.

Competence, Awareness and Training Procedure

A comprehensive, audit-ready Competence, Awareness and Training Procedure establishing a systematic approach to managing personnel competency across the full employee lifecycle.

Concessions/Deviations Request Form

Authorise and document deviations from specified requirements with control and traceability using our ISO-compliant Concessions/Deviation Form, designed to meet ISO 13485, ISO 27001, and ISO 9001 governance and audit requirements.

Configuration and Change Management Procedure

A comprehensive, audit-ready Configuration and Change Management Procedure covering the full change lifecycle. Applies across IT systems, manufacturing, facilities, supply chain, product design, and more. Suitable for ISO 13485, ISO 9001, and ISO 27001 compliance, and fully customisable to your organisation.
ReguLogix Consulting Ltd
AboutServicesContact

This site is governed solely by applicable laws and governmental regulations for England and Wales.
Use of this site constitutes your consent to application of such laws and regulations and to ourPrivacy Policy. Your use of the information on this site is subject to the terms of our  Legal Notice. Cookie Policy

Copyright © 2024 ReguLogix Consulting Limited. All Rights Reserved.