Industry Standard Compliance

Lathrop Engineering develops products in compliance with industry standards and has been ISO certified since 1998. The design and engineering processes we follow during development are compliant with either FDA Quality System Regulations or the relevant international standards for your specific product. We can readily adapt our quality system to use your existing systems, or apply our own compliant quality system if yours are still under development.

 

  • FDA QSR
  • Design History File
  • Device Master Record
  • Human Factors Analysis
  • ISO 9001 Certified
  • Take product to CE mark
  • IEC 60601 and 61010
  • Documented Design Standards
  • ISO 13485
ISO Certified
 

 

Compliant design control and product development process.