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Design and development plan A 1 (7)

Written/updates by Date Effective date/reference

Reviewed by Signature Date

Approved by Signature Date

This is a free template. You may find a premium version of this template on Gantus.com that you can
purchase.

What this is
This template will provide you with a framework to complete your design and development plan. It may
also be used as a benchmark on your existing plan. The template includes topics as required by clause
7.3.2 of ISO 13485:2016 and §820.30(b) as required by 21 CFR 820.

Why it is useful
A design and development plan is required to ensure that the design process is appropriately
controlled and that device quality objectives are met.

How to use it
1. If you are developing a brand-new product, establish as much as possible of this plan in the
planning phase of your project.
2. The design and development plan should be maintained, meaning that it should be updated
throughout the project. The updated document should be reviewed and re-approved.
3. After completing the project, the obsolete versions of the design and development plan will be
part of the Design History File.
In this template, instructions and/or explanations are included using blue italic texts such as these.
Instructions and explanations should be removed before review of the document. All texts that are not
blue are example texts that can and should be edited by you. Texts that most certainly should be
replaced or updated are identified by the { and } characters. They should be removed and the example
text customized to work with the current project.
For more information on how to use this template, visit http://gantus.com/templates-help
This document is protected by the terms and conditions accepted during the check-out process at
gantus.com. It may be used for your company internal use, but may not be resold or distributed in any
other way. Please respect this and contact support@gantus.se if you should find this document where
you believe it should not be.
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Design and development plan A 2 (7)

1 Purpose
The purpose of this document is to define the goals, strategies, roles, responsibilities and methods
for performing the development of the {product name} product within {project name}. The project
number is {01}.

2 Scope

The document starts with the design phase, not the planning phase, because this document is the
output from the planning phase. Please also note the difference between design release and product
release, where design release means that the product type may be sold to a specific market, whereas
product release is the release of a product or batch from production to market. This plan does not
cover product release from ongoing production.
Some regulatory people would say that design transfer shall be in a separate plan. You can do that,
but there is no requirement on making it separate. In fact, it can be argued that keeping all the plans in
one place makes more sense.
This Design and Development Plan covers ...

3 Contents

The Table of Contents have been created by inserting a Table of Contents (native function in MS
Word). If you need to update it, select and press F9.
1 Purpose..........................................................................................................................................1
2 Scope..............................................................................................................................................1
3 Contents.........................................................................................................................................2
4 Goals and objectives.......................................................................................................................2
4.1 Background and effect goal....................................................................................................2
4.2 Project objectives...................................................................................................................3
4.3 Project objectives priority.......................................................................................................3
5 Scope baseline................................................................................................................................3
5.1 Product scope description......................................................................................................3
5.2 Major deliverables..................................................................................................................3
5.3 Exclusions...............................................................................................................................3
5.4 Assumptions...........................................................................................................................3
5.5 Requirements documentation................................................................................................3
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Design and development plan A 3 (7)

6 Project organization plan................................................................................................................4

6.1 Project organizational structure.............................................................................................4
6.2 Resources...............................................................................................................................4
6.3 Responsibilities and authorities..............................................................................................4
7 Design and development documentation......................................................................................4
8 Change history................................................................................................................................4
9 Schedule, development stages and responsibilities.......................................................................5

4 Goals and objectives

4.1 Background and effect goal

Describe the effect that you want from executing the project. The product itself has no intrinsic value,
but you want it to create something, a turn-over, revenue, market share or similar.
What created a business need? The magnitude of the need? This information should be available from
the Project Charter.
The purpose of the project is …

4.2 Project objectives

The project has the following objectives…
1. Develop a system according to the scope baseline of this project plan
2. Completed according to the baseline budget referenced in this plan
3. Complete the project no later than {XXX}

4.3 Project objectives priority

This section is not a regulatory requirement, but very useful to have. It helps you agree on the priorities
in the project and align expectations. Never write anything else than safety as the priority. Update the
others to suit your situation.

5 Scope baseline

5.1 Product scope description

This is the short narrative description of what is to be developed. It could be an executive summary of
the resulting product.
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Design and development plan A 4 (7)

The product shall consist of …

-

5.2 Major deliverables

This is a top-level description. There will be a lot smaller deliverables that will be part of the Design
History File/Medical Device File, they may be defined in section 9.
The project has the following major deliverables…

5.3 Exclusions
The exclusions are included to manage expectations. Adding things to this section will many times lead
to good discussions on what should be part of the project and not. But ultimately, it is the project
managers tool to ensure the steering committee does not get the wrong idea of what to expect.
The following parts/deliverables are not a part of the project…

5.4 Assumptions
The following assumptions are considered to be true for planning purposes…

5.5 Requirements documentation

The requirements for the product can be found in the Requirement Traceability Matrix {XXX}.

6 Project organization plan

6.1 Project organizational structure

Include external organizations if you outsource work packages or complete processes to for example
external design house or contract manufacturer and sterilizer. Add contact persons for communication
with external parties and make sure it is in line with what is defined in quality agreements.
Don’t get too creative on the organization chart. It is easy to get carried away making strange looking
organizational structures that no one will understand. Try to stick to something similar to the example
below which represents best practice.
Below is the organization chart of the project…

6.2 Resources
This is not a mandatory section if you have covered the personnel already in your schedule and
organizational chart, but it also serves as a very clear reminder of what resources the project has been
promised.
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Design and development plan A 5 (7)

6.3 Responsibilities and authorities

The Steering group is responsible for…
The Project Manager is responsible for…
-

7 Design and development documentation

If you don’t have company procedures for Document control, you should include information on how to
name, review, approve and archive documents in this section.
Documentation will be controlled according to applicable procedures of the Company’s QMS.

8 Change history

Revision Ref Description

A Whole document New release

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Design and development plan A 6 (7)

9 Schedule, development stages and responsibilities

This table can be customized to your needs, for example by making the deliverables list more granular.
Fill in the responsible persons in the right column. If it is an external organization, you may want to
note the person’s/function name and organization. For tasks or dates you still don’t have, put in TBD
as in To Be Determined. Remember to the correct name before the work on a specific deliverable is
started.
The table below assumes that the product will comply both with US and EU requirements.
Deliverable Description/reference Responsible (support and/or
contributors within
parenthesis)

Initiation phase, {start week – finish week}

Planning phase, {start week – finish week}

Design, Design transfer, Design verification phase, {start week – finish week}
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Design and development plan A 7 (7)

Design validation, {start week – finish week}

Design release, {start week – finish week}