Design & Prototype Verification
Compare prototype connector behavior against the relevant reference interface and intended assembly condition.
- Reference interfaces
- Prototype comparison
- Fixture adaptability
- Functional verification
Solution
Medical Device Connector Verification for R&D and Manufacturing
Plan connector verification from prototype evaluation and design verification through supplier qualification, incoming inspection, release testing and periodic review.
Standard, interface, method, fixture, measurement and records reviewed together.
Planning principle
Connect design decisions to repeatable connector verification
Manufacturers may need different controls during prototype evaluation, design verification, supplier qualification, incoming inspection and release testing. The setup should follow the product lifecycle and the applicable connector requirement.
- 01Prototype evaluation
- 02Design verification
- 03Supplier qualification
- 04Incoming inspection
- 05Production / release testing
- 06Periodic verification
Product lifecycle
Medical device connector verification from R&D to production
Use a consistent reference interface and measurement approach while adapting the depth of verification to each lifecycle stage.
Design Verification
Define the applicable method coverage and repeatable measurement conditions for formal verification work.
- Applicable methods
- Controlled assembly
- Repeatable measurement
- Engineering records
Supplier Qualification
Use controlled reference interfaces and selected checks to compare connector samples from proposed suppliers.
- Connector comparison
- Incoming samples
- Reference interfaces
- Recorded results
Incoming Inspection
Use gauges and selected functional checks for characteristics included in the incoming inspection plan.
- Gauge checks
- Selected functional checks
- Lot identification
- Acceptance records
Production / Release Testing
Apply repeatable fixtures and selected verification methods at the frequency defined by the quality plan.
- Repeatable fixtures
- Selected methods
- Release criteria
- Result traceability
Periodic Verification
Control reference products, calibration status and measurement records over the equipment lifecycle.
- Reference product control
- Calibration status
- Periodic checks
- Measurement records
Configuration decisions
Define the verification scope for the current lifecycle stage
- Product stage
- Prototype, design verification, supplier qualification, incoming or release
- Connector
- Application family, DUT side and mating interface
- Comparison
- Reference connector, gauge or approved comparison sample
- Method
- Functional, mechanical or dimensional result required
- Control
- Fixture, assembly condition and repeatability expectation
- Evidence
- Drawing, method, report, calibration and traceability records
Engineering review
Review the connector verification plan with engineering
Provide the product stage and available connector information so the reference interface, method and fixture scope can be reviewed before quotation.
- Product and lifecycle stage
- Applicable standard
- Connector family and DUT side
- Prototype or production drawings
- Required verification methods
- Expected records and quantity