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 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

 

Aproio: we analyze, design, build & test medtech and other highly regulated products

Documentation & Control