ENGINEERING GUIDE
Medical injection molding supplier: questions to ask
Use this checklist to compare cleanroom, validation and quality-system capability.
Medical molding programs need more than a press list. Confirm the cleanroom classification, resin and lot traceability, mold maintenance, process validation approach and the inspection records delivered with each batch.
Key questions to cover in an RFQ
- ISO 13485 scope and controlled documentation
- Cleanroom class, environmental monitoring and gowning
- Tooling ownership, maintenance and change control
- Dimensional, cosmetic and functional acceptance criteria