CNC Machining for Medical Equipment and Device Development

Component Manufacturing Under the Customer’s Controlled Requirements

PiPrecision currently operates an ISO 9001-certified system. ISO 13485 is a targeted standard, not a current certification. The device manufacturer remains responsible for device classification, regulatory submission, risk management, validation, and final product release.

• Material grade and condition, heat or lot traceability, certificates, and prohibited substitutions.
• Burr and edge condition, surface texture, passivation or finishing, cleanliness, packaging, and handling requirements.
• Critical dimensions and GD&T, inspection method, sampling or 100% inspection, and report format.
• Drawing revision, approved changes, nonconformance authorization, and required record retention.
• Patient-contact, implant, sterilization, biocompatibility, UDI, DHF, DMR, DHR, and FDA-related requirements must be explicitly scoped and cannot be inferred from general machining capability.

Project Evidence and Regulatory Boundaries

Published case results describe specific customer projects. PiPrecision does not grant FDA clearance, certify the finished device, or transfer one project’s validation to another part.

Before quoting, identify whether the component contacts a patient or sterile field, enters a validated cleaning or sterilization process, requires medical-grade material certification, or must be produced by an ISO 13485-certified source.

Documented Project Examples

Results below are specific to the linked project, part, volume, process, and inspection scope. They are not universal capability guarantees.

Engineering Resources

Use these guides to prepare drawings, tolerances, finish requirements, and inspection expectations before RFQ.