Design and Development Procedure - ISO 13485

ISO 13485: 2016 +A11 2021

QMS.7.3.0 - QP - Design and Development Procedure

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which can then be modified to suit your company branding/marketing requirements.

Why do I need a Design and Development Procedure?

• ISO Standard 13485 requires that organisations seeking certification shall document procedures for design and development such as:
  • the design and development stages,
  • the verification and validation activities that are appropriate at each design and development stage,
  • the methods needed to ensure traceability of design and development outputs to design and development inputs.
• This template will provide you with the framework for creating your own procedure and show compliance with the requirements of the standard.

What are Design and Development Outputs and Inputs?

• The design inputs are the physical and performance requirements of a device that are used as a basis for device design.
• Inputs can include:
  • the product description
  • the intended use
  • the needs of the user/patient

• The Design Outputs are the results of a design effort at each design phase and at the end of the total design effort.

• Outputs should:
  • contain or reference product acceptance criteria,
  • meet requirements set out in the design and development inputs.
• The template will help your organisation set out your design and development inputs and outputs in a complete and unambiguous fashion that will demonstrate compliance with the standard.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.