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Mechanical Engineering . Medical Device Design / Analysis 
. Component Selection . Hydraulics . Extracorporeal

Mechanical Engineering

Design control compliance services are intended to help companies comply with the design control requirements of the FDA (CFR 820.30), ISO 9001:1994/ISO13485, and ISO 9001:2000. The following are services we provide:

Mechanical Systems Analysis

  • Failure analysis
  • Trade-off studies
  • Component Selection
  • Manufacturing technique selection

Mechanical Design

  • Concept
  • Analysis
  • Design
  • Solid Modeling
  • Prototyping
  • Testing
  • Manufacturing Process

Solid and Fluid Mechanics -- Analysis and Testing

Electromechanical Development Material Selection -- Including FDA/Medical considerations

Standards Based Design (Examples)

  • ASTM series standards
  • UL 94
  • ISO 10993

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