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Example Device Design Proposal

Example Device Design Proposal

To give you an idea of  what should be included in a design proposal, here is an example device design proposal that outlines the key deliverables and documentation items that a full proposal should address in detail.

Voler Systems div. of Strawberry Tree Inc.

Example Device Design Proposal

Voler Systems Division of Strawberry Tree Inc. 949 Cascade Drive Sunnyvale, CA 94087 Tel. 408-245-9844 / Fax. 408-245-8608

1. Summary

This is an example proposal for the development of an example medical device. Voler Systems has many years of experience with electronic and mechanical design for medical devices. We have a Design Control process that has been approved to meet FDA and CE requirements.

The design will be according to Example Design Requirements, XYZ Corp dated 1/15/09. Example design feature X is based on proprietary IP of XYZ Corp. It incorporates a custom module to be provided by XYZ Corp. The remainder of the technology uses standard components and standard design procedures.

The design process will be as outlined in section 3. Voler Systems will work with XYZ Corp to develop a specification that incorporates all the requirements that have identified in a way that is measurable. This document will be used as the basis of design verification and validation. Voler Systems will be responsible for verification. XYZ Corp will be responsible for validation, with assistance from Voler Systems. Voler Systems will create the Device Master Record and assist in transferring the design into manufacturing.

Voler Systems will provide the following project deliverables as part of the Device Master Record.

Device specification
Bill of materials
Gerber files of layout
PCB Assembly drawing
Mechanical drawings
Compiled firmware
Firmware source code

XYZ Corp will provide the following documentation for the Device Master Record.

Production process specification
Quality assurance procedures
Acceptance criteria
Packaging and labeling specifications
Installation, maintenance, and servicing procedures

3. Schedule and Cost

This project can be completed in about xx weeks. A schedule will be agreed upon at the time an order is placed. Voler Systems will schedule the work in consultation with you. Voler Systems realizes the urgency of meeting the terms of this contract and will make its best efforts to complete milestones early.

This schedule will be updated with dates at the beginning of the design, no later than the first design review meeting.

2. Problem Statement

Date: February 12, 2009

Proposal No.: V-XXX

Key Customer Contact:

John Doe

XYZ Corp

123 Main St.

San Jose, CA 94000

Phone: 408-123-4567

Email: john.doe @ xyzcorp. com

Key Voler Systems Contact:

Walt Maclay
President and Chief Engineer, Voler Systems
Email: waltermaclay @ volersystem. com

Ending 3rd Party
Description Hours Week Cost
Design Review
Analog circuit design
Digital circuit design
Preliminary mechanical design
Design Review & Commit to Next Phase
Parts purchasing
Breadboard assembly
Breadboard testing
Mechanical design
Design Review & Commit to Next Phase
Parts purchasing
Layout preparation
Layout checking
PCB fabrication
PCB assembly
Fabrication of prototype enclosure
Testing of PCB
Testing of prototype unit
Design Review & Commit to Next Phase
Electrical design changes
Mechanical design changes
Layout changes and checking
PCB fabrication (final)
PCB assembly (final)
Fabrication of enclosure (final)
Testing of PCB (final)
Testing of complete unit (final)
Final design review

4. Terms

Terms and conditions are arrived at by negotiation and mutual agreement between Voler Systems and our customers. Specific terms and conditions will very depending upon our customer’s needs.

5. Signature

Walter N. Maclay, President ______________________________ ____ Date _________ Acceptance by ______________________________ ______________ Date _________ Printed name ______________________________ ______ Title ____________________


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