Regulatory Documentation, Support for ISO 13485 and

UL/CE Testing

Elite Engineering’s proven design method’s natural extension creates and maintains the design history files documenting the initial product design, any changes and iterations in compliance to ISO 13485. At the start of any project with the Client’s request, we can generate Design History, technical files, and Design Control Procedures. Not every Client requires this level of documentation. So we tailor your project to your Quality requirements.

As part of the design process we can supply:

  • QSR Requirements/Quality Control

  • Design input and output (IO)

  • Software Requirements Specification (SRS)

  • Design Verification Testing

  • Hazard/Risk Analysis

  • Production Documentation

  • GMP requirements

  • Documentation to support 510K submission

To see our product solutions for smart sensors go to our Modules web page.

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