Seamless US Market Entry for Medical Devices with Intertek

Achieving US market entry for medical devices requires navigating a complex landscape of regulatory requirements, including FDA approval and, for certain devices, testing and certification from an OSHA Nationally Recognized Testing Laboratory (NRTL). Medical devices used in workplace environments, such as hospitals and laboratories, may need to meet these additional safety and performance requirements. Intertek offers the expertise and capabilities to help manufacturers streamline the compliance process and accelerate their path to market.

As a recognized NRTL, Intertek conducts testing and certification to ensure compliance with OSHA’s workplace safety standards, addressing critical requirements for devices such as hospital equipment, diagnostic tools, and powered medical systems. For selling medical devices in the U.S., Intertek’s accredited services include testing under ISO/IEC 17025 and certification under ISO/IEC 17065, providing manufacturers with the confidence that their devices meet the highest safety and quality standards. Our ETL Certification mark is recognized by Electrical inspectors, building code officials, and other Authorities Having Jurisdiction (AHJs) across the United States.

In addition to workplace safety compliance, Intertek provides comprehensive support for FDA submissions, offering data and documentation that meet the stringent requirements for FDA approval. By integrating NRTL certification with FDA compliance processes, Intertek ensures that manufacturers can meet all necessary regulatory standards efficiently, reducing delays and ensuring a faster time to market.

Whether your device requires compliance with FDA regulations alone or additional NRTL certification, Intertek simplifies the process. Our deep expertise in regulatory requirements, state-of-the-art testing facilities, and commitment to precision and efficiency ensure that your devices meet the necessary standards for selling medical devices in the U.S..

Contact us today to learn how our comprehensive testing and certification solutions can help you navigate U.S. regulatory requirements and bring your medical devices to market with confidence.

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