Design and Development Procedure - ISO 13485

Design and Development Procedure - ISO 13485

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ISO 13485:2016 QMS Template - Design and Development Procedure (QMS.7.3.0 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Design and Development Procedure template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

  • Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
  • Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
  • Compliance Assurance: Utilizing our template helps you maintain effective design and development procedures, demonstrating robust quality management as required by ISO 13485:2016.

Why Do You Need a Design and Development Procedure?

The ISO 13485 standard mandates that organizations seeking certification must document procedures for design and development, including:

  • Design and Development Stages: Clearly defining each stage of the design and development process.
  • Verification and Validation Activities: Outlining appropriate activities at each design and development stage.
  • Traceability: Ensuring traceability of design and development outputs to inputs.

This template provides a comprehensive framework for creating your own procedure and ensuring compliance with the standard.

What are Design and Development Outputs and Inputs?

  • Design Inputs: These are the physical and performance requirements used as a basis for device design, including:
  • Product description
  • Intended use
  • User/patient needs
  • Design Outputs: These are the results of the design effort at each phase and at the end of the total design effort, ensuring they:
  • Contain or reference product acceptance criteria
  • Meet requirements set out in the design and development inputs

Our template helps your organization clearly define and document your design and development inputs and outputs, demonstrating full compliance with the standard.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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