ISO 13485 Templates

Implementing ISO 13485:2016 requires comprehensive documentation to meet regulatory standards. Our ISO 13485 templates provide medical device companies with ready-to-use documentation that simplifies compliance. These professionally designed templates include complete manuals, procedures, and forms that address critical requirements like complaint handling, CAPA, and risk management. Save hundreds of hours of development time with our expert-crafted templates that align with global regulatory expectations. 

Why Choose Our ISO 13485 Templates? 

  • Comprehensive Coverage – Complete set of templates covering all ISO 13485:2016 documentation requirements. 
  • Regulatory Compliant – Aligned with FDA, EU MDR, and QSR, and global regulatory standards. 
  • Customisable & Ready-to-Use – Simply add your company information and implement immediately. 
  • Expert-Developed – Created by regulatory professionals with decades of medical device experience. 
  • Regular Updates – Templates updated to reflect the latest regulatory changes and interpretations. 

These templates provide structured guidance through complex ISO 13485 requirements including document control, production planning, design controls, and complaint handling processes – ensuring your quality management system is both compliant and efficient.