ROHS2 compliance for drug delivery device

ROHS2 compliance for drug delivery device

The Customer:

World leader in Nitric Oxide drug delivery system for critical neonatal care

Problem Statement:

Client intended

  • Provable reduction of restricted substance to compliant levels (RoHS2 including REACH) in its Nitric Oxide drug delivery device, its accessories and packaging
  • Re-engineering of the existing drug delivery system to ensure RoHS2 compliance
  • Streamlining the documentation procedure to ensure fast and efficient compilation of data for components and materials used in the device, the accessories, disposables & packaging
  • Ensure continued ability to place the “CE” mark through compliance to the MDD in Europe
  • Ensure better product reliability through active control of RoHS electronic component lead plating and soldering process

Project Description & Scope:

  • Technical assessment of Nitric Oxide drug delivery device
  • Detailed study of product in totality usings Bill of Material (BOM), schematics, drawings etc.
  • Re-engineering of hardware and mechanical components of Nitric Oxide drug delivery device
  • Selection of functionally equivalent RoHS components
  • Verification of RoHS compliance certification/material declaration and certificate of each component
  • Fabrication of RoHS compliant hardware PCBs
  • Functional and integration testing
  • EMI/EMC pre-compliance testing
  • RoHS documentation required for CE marking
  • Drawing the missing components (Electronic & Mechanical) & updating the BOM

Business Benefit:

  • Time consuming activity of collecting Certificate of Compliance done by Tata Elxsi’s team
  • Redesigning PCB without much involvement of the core design team
  • Ensuring order fulfillment and business continuity in EU and expansion into Japan and BRIC markets

Tools Used:

PCB Design

  • PADS version 9.5
  • Altium version 10

Mechanical Drawings

  • SolidWorks x64 Edition professional 2012