Documentation & Control

We offer a comprehensive set of product development documentation
to support our informed design process.

  • Plans to guide the development.
  • Product definition documents to record product requirements and specifications
  • Transfer design files to enable manufacturing to build a product with predictable results (design history file, device master record and device history record)
These documents are securely managed throughout the development process.
  • Documents are routed and approved over secure network, and encrypted and stored in Citrix Sharefile:
    • We meet administrative/procedural requirements of Title 21 CFR Part 11
    • Sharefile is identity-access-controlled (username/password/two-step verification required)
    • Transfers to Sharefile cloud are over Secure Socket Layer (SSL) / Transport Layer Security (TLS)
    • Sharefile storage is in SSAE-16 audited data centers
Acronyms used in the Comprehensive Documentation graphic are defined below:
  • PRD – Product Requirements Document
  • HA – Hazard Analysis
  • SRD – Software Requirements Document
  • VVP – Verification & Validation Protocol
  • UID –  User Interface Requirements
  • RA – Risk Analysis plan
  • SSR – Sub-System Requirements
  • TM – Trace matrix
  • SSD – Software Specification Document
  • HDD – Hardware Design Document
  • ECAD – Electrical CA
  • FMEA – Failure Mode Effect Analysis
  • FDD – Firmware Design Document
  • MCAD – Mechanical CAD
  • DHF – Design History File
  • DMR – Device Master Record
  • DHR – Device History Record
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