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

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• 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)

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These documents are securely managed throughout the development process.

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• 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 required)

  • Transfers to Sharefile cloud are over Secure Socket Layer (SSL) / Transport Layer Security (TLS)

  • Sharefile storage is in SSAE-16 audited data centers

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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 CAD

• FMEA – Failure Mode Effect Analysis

• FDD – Firmware Design Document

• MCAD – Mechanical CAD

• DHF – Design History File

• DMR – Device Master Record

• DHR – Device History Record