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

Mechanical Drawings

Share to:

Design Digital