Project Planning
Design and Development Project Planning, Design Changes, Design Controls, Design History File, Design Input, Design Output, Design Review, Design Transfer, Design Validation, Design Verification, FDA, Medical Devices, QSR
Design and development plans can be a powerful tool to provide business value to product development.
To satisfy FDA QSR requirements, design and development plans need to:
- Describe or reference the design and development activities
- Define responsibility for implementation of those activities
- Identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process
- Be reviewed, updated, and approved as design and development evolves
One easy way to do this is to create a document for each project entitled “Design and Development Plan, Project xyz”, and have at minimum sections with the following names:
- Design and Development Activities
- Design and Development Responsibilities
- Organizational and Technical Interfaces
- Plan Review and Approval
A simple way to approach the initial planning for medical devices under Design Controls, is to have one sentence on the “Big Ten” (General, planning, Design input, Design output, Design review, Design verification, Design validation, Design transfer, Design changes, Design history file).
I find folks wait until design and development is well underway before writing the initial D&D Plan, often from the perspective “we don´t really know what the design activities will be”. My perspective is to write an initial D&D Plan with what you know at the beginning, have it reviewed and approved, then update, review and approve the plan with additional detail “as design and development evolves”.
Here´s a sample plan for day one of a project:
This document is the plan to develop the xyz, and to control the design of the device in order to ensure that specified design requirements are met.
Design and Development Planning
This plan describes or references the design and development activities and defines responsibility for their implementation, and is the responsibility of Bob Leadsda Project.
Design Input
Design Input will be documented in the XYZ Product Requirements document, and will include input from Marketing (Debbie Knosda Customer) and Clinical (Steve Knosda User). This document is the responsibility of Jessica Keepsda Specks.
Design Output
All Design Output will be documented in terms that allow an adequate evaluation of conformance to design input requirements, and will be the responsibility of Shawn Designsda Mech, Ed Designsda Boards and Janet Wrightsda Code.
Design Review
Design Review will be planned and conducted at appropriate stages of the XYZ device’s design development, and is the responsibility of Bob Leadsda Project.
Design Verification
Design verification for the XYZ will be planned and conducted at appropriate stages to confirm that the design output meets the design input requirements, and is the responsibility of Sherry Varifizda DeZine.
Design Validation
Design validation for the XYZ will be planned and conducted at appropriate stages to ensure that XYZ devices conform to defined user needs and intended uses, and is the responsibility of Gary ValAdaetzda DeZine.
Design Transfer
Design transfer for the XYZ will be planned and conducted at appropriate stages to ensure that the XYZ device design is correctly translated into production specifications, and is the responsibility of Jill Makshurwekan Makit.
Design Changes
Design changes for the XYZ will be identified, documented, validated or where appropriate verified, reviewed, and approved before their implementation.
Design History File
A Design history file will be established and maintained for the XYZ, and is the responsibility of Bob Leadsda Project.