A medical PCB assembly RFQ should define the manufacturing scope, product configuration, required evidence and approval responsibilities. Product-specific requirements come from the device’s design, risk management and quality processes. They cannot be replaced by a generic list of certifications or an unsupported claim of prior medical-device experience.
Define the supplied assembly and its boundaries
State whether the request covers bare boards, populated assemblies, programmed units or a complete integrated product. Identify what the assembly connects to and which requirements are controlled at the board level versus at the complete-device level. Include the relevant drawings and test definitions without assuming that the supplier will infer the intended use from a component list.
Assign the design authority and the people responsible for supplier quality and regulatory decisions. The project team should establish the applicable quality-system and documentation requirements. For US device projects, refer to the FDA’s current QMSR information. A manufacturing proposal should be evaluated within the device manufacturer’s controlled processes.
Build an evidence-based procurement checklist
| RFQ subject | Information to agree |
|---|---|
| Configuration | Drawing, BOM, firmware, variants and approved alternate parts. |
| Traceability | The required links between materials, assemblies, process records and test results. |
| Verification | Test limits, conditions, fixture needs and result retention expectations. |
| Deviations | Which changes require approval and how approval is documented. |
| Supplier evidence | Applicable current documents, scope and project-specific process information. |
Compare test coverage and residual questions
Ask what each inspection or test actually checks. Visual inspection, electrical testing and product-level functional testing provide different information. Identify any functions or interfaces that remain untested at the supplied assembly level. The responsible product team should decide how the overall verification plan addresses those gaps.
For example, a board-level test may verify digital communication while the final device also depends on a calibrated sensor or mechanical interface. Record the boundary between the supplier’s test and the final-device process. A quotation for the board test should not be interpreted as evidence that the complete device’s performance has been established.
Prepare for the first build and repeat production
- Resolve open DFM questions before authorizing the manufacturing revision.
- Agree first-article review criteria and the required records.
- Control firmware, test software and fixture revisions.
- Define handling of failures, rework, retest and nonconforming material.
- Establish change notification for materials and manufacturing processes.
This site’s medical-device certifications, customer history, qualified processes and manufacturing capabilities are [NEEDS CLIENT INPUT]. No customer case study or product approval is claimed. Prepare the detailed handoff with the NPI checklist and PCB test requirements. Discuss your assembly scope