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