Medical Devices
 

The process of using Computer Numerical Control (CNC) machines to manufacture medical devices typically involves several well-defined steps to ensure precision, quality, and compliance with regulatory standards. Here’s an outline of the typical steps your company can follow:

1. Concept Design and Requirements Gathering

  • Define device specifications: Collaborate with biomedical engineers and clinicians to determine the device’s dimensions, materials, and functionalities.
  • Create a CAD model: Use software like SolidWorks, AutoCAD, or Fusion 360 to design a detailed 3D model of the device.

2. Material Selection

  • Choose biocompatible materials such as stainless steel, titanium, PEEK, or medical-grade polymers, depending on the device’s application.
  • Ensure materials meet ISO 10993 (biological evaluation) standards for medical devices.

3. CNC Programming

  • Convert the CAD model into CNC machine-readable instructions using CAM software (e.g., Mastercam, Fusion 360, or GibbsCAM).
  • Define tool paths, cutting strategies, and speeds to achieve precise tolerances.

4. Prototype Development

  • Manufacture a prototype for initial evaluation.
  • Test for functionality, structural integrity, and compliance with medical standards.
  • Iterate designs based on feedback from testing and stakeholder reviews.

5. Validation and Regulatory Compliance

  • Perform design validation: Ensure the device meets functional and safety requirements.
  • Document manufacturing processes for compliance with ISO 13485 (Medical Devices Quality Management System) and FDA regulations.
  • Conduct risk assessments under ISO 14971 (Risk Management for Medical Devices).

6. CNC Machining

  • Set up the CNC machine and load the material.
  • Run the CNC program to manufacture the device components.
  • Use quality control tools (e.g., probes, calipers) to monitor dimensions and tolerances during machining.

7. Surface Finishing and Post-Processing

  • Perform deburring, polishing, or coating to meet medical device standards for cleanliness and smoothness.
  • Apply any necessary surface treatments (e.g., passivation for stainless steel or anodizing for titanium).

8. Quality Assurance and Testing

  • Inspect components for precision using Coordinate Measuring Machines (CMMs), optical scanners, or microscopes.
  • Conduct functional tests, such as mechanical stress testing or biocompatibility assessments.

9. Assembly and Packaging

  • Assemble individual components if required.
  • Package devices in sterile conditions according to ISO 11607 (Packaging for Terminally Sterilized Medical Devices).

10. Sterilization and Delivery

  • Sterilize the devices using approved methods (e.g., gamma radiation, ethylene oxide, or autoclaving).
  • Label and document for traceability per UDI (Unique Device Identifier) regulations.
  • Ship to customers or distributors.

11. Continuous Improvement

  • Gather feedback from end-users and regulatory audits.
  • Update manufacturing processes and designs as needed to improve efficiency and compliance.
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