Kirk Kitchen Consulting: Embedded Systems design consulting services for large and small companies since 1986.

You'll see references to FDA guidance because I have been consulting in the area of software-containing medical devices for a number of years.  I have designed embedded controls for everything from consumer gadgets to medical instruments.  For practical reasons, I have gained a detailed understanding of the Quality System Regulation and other FDA regulatory requirements for medical device manufacturers.

• HARDWARE AND FIRMWARE DESIGNS: Schematic Capture, PCB Layout, Programming in C, C++, Assembly, BASIC etc.
• PROTOTYPES AND PRE-PRODUCTION BUILDS: PCBs, Cables, Subassemblies and Machining Services.
• DOCUMENTATION: Development Plans, Requirements, Design, Risk Management, Verification and Validation, Reverse Engineering.
• SYSTEM TEST: Test Fixtures, Verification, Validation.
  
• QSIT, FDA Inspection Preparation and FDA Form 483 and Warning Response, especially for small companies.
• WIKI system for project notes and online Quality System and Design/Document Controls.