Introduction to Manufacturing

As part of our full design services, BCA will provide electronically to you a complete documentation set following your design acceptance.

For electronics designs, this would include:

• Schematics
• Bill of Materials (BOM)
• Printed Circuit Board (PCB) layout
• Hazards Analysis and FMECA (for Medical Devices)
• Hardware Requirements Specification
• Hardware Design Specification
• Hardware Qualification Test Plan
• ECOs

For software development this would include:

• Hazards Analysis and FMECA (for Medical Devices)
• Software Requirements Specification
• Software Design Document
• Source code
• Toolchain documentation
• Software Verification Test Plan
• ECOs

Companies with mature and deployed design processes will likely assimilate this documentation into their system and use their own internal resources to introduce and support the design during the manufacturing process.

For a company without a mature design process, however, BCA can offer the service of New Product Introduction. These services can include:

• Identification and introduction to a reliable contract manufacturing partner
• Any necessary process development
• Design of any necessary test fixture or validation capability
• Training of CM personnel
• Pilot process oversight
• First article approval