Závitovkové prevody pre Medical Devices and Pharmaceutical Equipment

Korea Ever-Power holds ISO 9001:2015 quality management system certification. ISO 13485 is a medical device manufacturer standard — it is technically applicable to manufacturers of medical devices, not to component suppliers. However, many medical device manufacturers require their component suppliers to demonstrate quality management capability equivalent to ISO 13485 clause 7.4 supplier qualification requirements. Korea Ever-Power satisfies this requirement through its documented supplier qualification questionnaire response, ISO 9001 QMS certificate, process capability data, and the medical device documentation package described in this guide. We do not currently hold ISO 13485 certification, but we can participate in medical device manufacturer supplier qualification audits as part of initial qualification.

A standard material certificate (sometimes called a certificate of conformance or CoC) is issued by the component manufacturer or supplier and states that the material meets a particular specification — for example, ‘AISI 316 stainless steel.’ It may or may not include actual measured elemental composition data, and it typically does not include a heat number (the unique identifier traceable back to the original steel mill’s production batch). A mill test certificate (MTC) or material test report (MTR) is issued by or directly traceable to the steel mill that produced the material. It includes the heat number, actual measured composition (including Mo% measured by spectrographic analysis), and mechanical properties measured on the specific heat. For medical device and pharmaceutical applications, only the mill test certificate provides the level of traceability required for ISO 13485, FDA, and GMP quality systems.

A worm gear inside a completely sealed housing that has no physical path of contact with the patient, patient fluids, or sterile surfaces is classified as a non-contact part under ISO 10993-1. Non-contact parts do not require biocompatibility testing. However, the device technical file should include a documented risk assessment confirming the non-contact classification — not simply assume it. If the sealed housing could theoretically fail and allow lubricant or particulate migration into a patient-contact zone, the risk assessment must address this scenario and confirm the risk is acceptably mitigated by the sealing design. Korea Ever-Power can provide outgassing data, particle generation data from salt spray test results, and housing IP rating confirmation to support this risk assessment.

No. The worm gear drive itself does not require FDA registration — that requirement applies to medical devices (as defined under 21 CFR Part 800 series). A pharmaceutical filling machine is production equipment, not a medical device, and its components do not require FDA registration. However, pharmaceutical equipment installed in FDA-inspected pharmaceutical manufacturing facilities must be designed, maintained, and documented in compliance with the FDA’s Current Good Manufacturing Practice (cGMP) regulations (21 CFR Parts 210, 211 for drugs). For the worm gear drives, this means: material documentation supporting the equipment qualification record, maintenance procedures including lubricant specification and change intervals, and a change control process for any component substitution.

The gear set itself can be dimensionally identical. The documentation required by the respective applications is different. For a standard industrial application, a material certificate and CMM report are typically sufficient. For a CE MDR medical device application, you also need: mill heat number traceability, ISO 10993-1 biocompatibility grouping reference, and in some cases surface finish verification. Korea Ever-Power can provide either documentation level from the same production batch of gear sets — the manufacturing process is identical; the documentation package level is selected at order placement. If you have both medical device and industrial applications for the same gear geometry, specify the medical device documentation level for all orders — the incremental cost is modest and having the documentation available for industrial applications where it is not strictly required creates no compliance problems.

As early as possible — ideally at the design input stage (Phase 1 of medical device development). At this stage, Korea Ever-Power can provide: confirmation of which precision class and material specification satisfies the expected application requirements; the documentation format that will be available for the technical file; lead time data for the likely specification (which affects design verification scheduling); and guidance on whether the required specification is a catalog standard, Level 2 modification, or Level 3 semi-custom. Engaging at design input prevents the common problem of specifying a gear that is technically achievable but for which documentation cannot be produced in the format required by the regulatory pathway — discovered only during design verification when the timeline for regulatory submission is already established.

For cleanroom compatibility, Korea Ever-Power provides: surface roughness measurement report (Ra value on functional surfaces, measurement location, equipment calibration certificate); material certificate (SS316 composition, confirming no materials prohibited by cleanroom compatibility guidelines); lubricant data sheet (vapour pressure at operating temperature, flash point, non-volatile residue content for outgassing assessment); and housing sealing specification (IP rating, seal material, test method). These four documents provide the data typically required for cleanroom qualification protocol evidence packages under ISO 14644-3 test and monitoring requirements. The cleanroom qualification itself is performed by the equipment manufacturer or facility operator — Korea Ever-Power provides the component-level data that feeds into that qualification.

Yes. For components supplied under our medical device documentation program, we retain production records, material certificates, inspection data, and process records for 7 years from shipment date. In the event of an adverse event investigation involving a component, we can provide: retrieval of original production records for the specific shipment batch; confirmation of all component identifiers and their link to material certificates; and if required, a technical statement from our quality management team confirming the component was manufactured and inspected in accordance with the specified requirements. We cannot provide clinical or biological investigation support — that is the device manufacturer’s responsibility — but we can fully support the device manufacturer’s component traceability investigation.