ISO 13485 Medical Devices Quality Management System Toolkit

Build a compliant, audit-ready Quality Management System for medical devices without starting from a blank page. This toolkit brings together 99 ready-to-use documents written to ISO 13485:2016, with risk management aligned to ISO 14971 and references to key regulatory frameworks such as the EU MDR, US FDA 21 CFR 820 and MDSAP. It covers the full QMS, from scope, documentation and management responsibility through resource management, design and development, purchasing, production and process validation, identification and traceability, and contamination control, to complaint handling, regulatory reporting, nonconforming product, CAPA, internal audit and management review.

What's Included

• Medical Devices Quality Management System Manual, Quality Policy and QMS Scope Statement
• 25 Procedures, including Risk Management, Regulatory and Legal Requirements, Document and Record Control, Infrastructure and Work Environment, Contamination Control, Design and Development, Purchasing and Supplier Control, Production and Process Control, Process Validation, Identification and Traceability (including UDI), Feedback and Complaints, Regulatory Reporting, Nonconforming Product, Corrective and Preventive Action
• Risk Management Plan, Risk Management File and Risk Management Report, plus Process Validation and Design and Development Plans
• 22 Records, including Medical Device Classification, Design Input, Output, Verification, Validation and Change Records, Device Master Record, Production Batch Record, Equipment Qualification, Environmental Monitoring, Cleanliness, Final Inspection and Product Release
• 19 Registers, including Regulatory Requirements, Medical Device, Risk Control, Approved Supplier, Calibration, Identification and Traceability, Nonconforming Product, Corrective Action and Customer Complaint, plus a Document Master List
• 7 Reports (Risk Management, Supplier Audit, Nonconforming Product, Internal Audit, Process Validation, Quality Performance, Product Quality Trend) and 3 Reviews (QMS Effectiveness, Purchase Order, Design Review)
• Product Specification, Internal Audit Programme and Checklist, Supplier Performance and Regulatory Compliance Evaluations, Training Needs and Customer Feedback Analyses, and a Competency Matrix
• Risk Assessment, Customer Complaint and Supplier Evaluation Forms, Document Change and Corrective Action Requests, and Management Review Agenda and Minutes

Who It's For

Medical device manufacturers, contract manufacturers, component and service suppliers, distributors and start-ups implementing ISO 13485, preparing for certification or an MDSAP audit, or building a QMS to support EU MDR or FDA requirements.

Format

Editable Microsoft Word (.docx) files, delivered in a single ZIP download. Instant download after purchase. Add your organisation's name and details, and the documents are ready to use.

After purchase, the complete bundle is available as a single ZIP file in My Account → Downloads.