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