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Manufacturing Transfer
When a Contract Manufacturer (CM) has not been identified by the client, we will establish the manufacturing requirements, identify and rank possible candidates using objective assessment of the CM’s capabilities, tour the candidates facilities with our client, and present our recommendations for the best candidate based on manufacturing needs.
Learn more about our Capabilities
We emphasize having the CM on board early in the development cycle to provide input into Design for Manufacturing (DFM), including DFA (Assembly), DFT (Testability), and DFR (Reliability). This collaboration provides for seamless integration into the manufacturer’s processes for end-of-life assessment, supplier management, PCB assembly processes, considerations for assembly, and testing.
On completion of design and testing, Pivotal will transfer the Design History File (DHF) to the client and the Device Master Record (DMR) to the contract manufacturer and assist the CM with BOM’s, suppliers, IQ/OQ/PQ, MPI’s, fixtures etc. leading to a successful introduction of the product.
Our Areas of Expertise
- Planning and Risk Management
- DFx occurs as part of development
- Design for Assembly (DFA)
- Design for Test (DFT)
- Design for Reliability (DFR)
- Contract manufacturer selection
- Device Master Record (DMR) – specifications, instructions (MPI), and Bill of Materials (BOM)
- New Product Introduction (NPI)
- Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Manufacturing Process Instructions (MPI)
- Manufacturing test instructions
- Production support
- Design of fixtures and methods – including in-process QC
- PCBA test (flying probe, ICT, functional)
- Risk management
- pFMEA input
- Interface with safety agencies such UL and Intertek
- Sustaining engineering support
