ISO 13485 Documents – Manual, Forms, Audit Checklist
The ISO 13485 Documents Toolkit includes a comprehensive set of ready-to-use templates—Quality Manual, procedures, forms, SOPs, flowcharts, audit checklist, and medical device files—designed for ISO 13485:2016 compliance. It helps organizations implement a Quality Management System for medical devices efficiently. Expert support and consultancy services are also available, saving time and cost in achieving ISO 13485 certification.