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Key Considerations for Medical Device Design

From Precision Incorporated

Opportunties for the development of Medical Magnetics and device evolution will require continual demanding physical characteristics and size, as well as more performance through design and design situations. These evolving characteristics will pose unique obstacles for successful magnetics solutions.

Regulatory:
*FDA, UL, IEC (Agency Requirements)
*Creepage/Clearance/Isolation
*Patient Connect Requirements
*Patient Contact Requirements

Quality & Reliability:
*Cleanliness
*Unique Test Requirements
*Materials & Process Traceability (Six Sigma CPK levels)
*Minimized Process Variation

Trade-Offs:
*Cost
*Size
*Performance

Physical:
*Miniaturization - Ultra fine Wire (less than 0.0006in)
*Biocompatibility
*Unique Form Factor
*Tight Tolerance
*Mechanical Integrity

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