RFQ Preparation Checklist
- Device classification and regulatory pathway (510(k), CE MDR, etc.)
- Sterilization method and cycle count (autoclave, EtO, gamma, e-beam)
- Biocompatibility requirements and coating specification
- Magnet geometry, tolerance, and air gap to sensor element
- Lot traceability, material certificate, and documentation requirements
- Annual volume and prototype-to-production timeline


