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Medical Device Design Considerations

 The Precision Factor

 Medical Device Design Considerations

Precision, Inc is a leader in the design and manufacture of magnetic components for the medical industry, including medical isolation transformers, toroidal power transformers, power inductors and rf coils and antennas.  Precision, Inc. understands the crucial responsibility that comes with being a strategic supply partner to a Medical Device Manufacturer. Precision, Inc. provides the highest quality design and workmanship in the industry.  The Company’s capabilities for Medical Grade Transformers include clean room facilities, winding expertise to 58 AWG and smaller, implantable devices, and ISO 13485 certification for magnetic components.  Contact us for custom medical grade transformers.

The development and evolution of the Medical devices and the required magnetic components will continually place demands on the physical characteristics, as well as improving the performance of the product and the design approvals situation.  These evolving characteristics will pose unique obstacles for successful magnetic solutions.

Regulatory

  • FDA, UL, IEC (Agency Requirements)
  • Creepage/Clearance/Isolation
  • Patient Connect Requirements
  • Patient Contact Requirements

Quality & Reliability

  • Clean room facility
  • Unique Test Requirements
  • Materials & Process Traceability (Six Sigma Cpk levels)
  • Minimized Process Variation

Trade-Offs

  • Cost
  • Size
  • Performance

Physical

  • Miniaturization - Ultra fine Wire 58 Gauge (less than 0.0006in)
  • Biocompatibility
  • Unique Form Factor
  • Tight Tolerance
Medical Grade Transformer Spec Sheet
Medical Grade Transformer Spec Sheet
   

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