Certifying Laser Diode Components a Quality Approach

To reduce regulatory paperwork on their part, customers of Class I laser diodes are requesting that these diodes be certified by the manufacturer with the Food and Drug Administration’s Center for Devices and Radiological Health (FDA/CDRH). This article describes the rationale behind this approach, the associated regulatory requirements and how a company can use its total quality management system to achieve both customer satisfaction and regulatory compliance. This article does not provide legal advice and readers should have any compliance program reviewed by their own legal counsel.