Medical devices must work as intended and expected when lives are on the line in an ER, OR, and even when implanted in the body.
When Medical Device Failure Is Not an Option
Medical devices must work as intended and expected when lives are on the line in an ER, OR, and even when implanted in the body. A medical device manufacturer relying on a metalworking machine shop must ensure that the shop operates to the highest standards of precision, compliance, and traceability. Here are four key points every medical device manufacturer should know about their metalworking machine shop:
- Regulatory Compliance (Especially ISO 13485 and FDA Requirements)
Machine shops must understand and comply with medical industry regulations, particularly ISO 13485 and relevant FDA Quality System Regulations (QSR) under 21 CFR Part 820. This includes maintaining documented procedures, ensuring material traceability, and implementing robust process controls. The shop should have validated processes, proper calibration records, and a history of successful audits or inspections. - Precision and Process Capability
Medical components demand extremely tight tolerances, especially for implants, surgical tools, and diagnostic equipment. The part manufacturers must demonstrate capability to hold micrometer-level tolerances, surface finishes, and geometrical accuracies. This includes having qualified machinists, modern CNC equipment, and a documented record of process capability studies (e.g., Cp, Cpk values) that show consistent part quality over time. - Cleanliness and Material Handling Standards
Medical device parts often require special attention to cleanroom-compatible manufacturing, biocompatible materials (like titanium or 316L stainless steel), and debris-free processing. The shop must use appropriate coolants, part washing/ultrasonic cleaning, and handling procedures to prevent contamination. Understanding and implementing Foreign Object Debris (FOD) control and clean packaging protocols is critical. - Traceability and Quality Documentation
Full traceability from raw material to finished part is a non-negotiable requirement. Reliable shops maintain records of material certifications (e.g., mill certs), inspection data, and batch histories. Additionally, they must be capable of providing first article inspections (FAIs), statistical process control (SPC) data, and non-conformance reports (NCRs) when required. Seamless integration with the manufacturer’s quality management system (QMS) is a major asset.
Patients put an extreme amount of trust in their doctors. Those same doctors put the highest level of trust in their equipment. They must believe in the reliability of their tools to successfully perform their jobs. Reliable machine shops, like Nolte Precision Manufacturing, implement all the specification requirements so those practicing medicine can live their Hippocratic Oath.