Comprehensive Solutions for Medical Device Testing, Certification, and Quality Assurance

Simplifying the complex world of medical device compliance requires a trusted partner with unparalleled expertise. Intertek is committed to helping you bring innovative and high-quality medical devices to market efficiently and confidently.

We offer comprehensive medical device assurance, testing and certification solutions designed to meet stringent regulatory requirements, including FDA guidance, 60601-1 standards, and other global standards. Our services ensure your devices not only comply with the latest safety and performance regulations but also gain faster market entry to every region around the world.

From electrical safety and EMC to cybersecurity, biocompatibility and beyond, our experts are well-versed in the challenges of today’s medical device regulatory and compliance landscape. Whether you’re developing never-before-seen technologies or improving existing FDA-approved medical devices, Intertek provides the assurance you need to succeed.

Intertek's Solutions for Medical Devices

Medical Device Testing and Compliance Solutions

Solutions to meet state-of-the-art standards on safety and electromagnetic compatibility (EMC), including IEC 60601-1, 60601-1-2, Home Healthcare, medical imaging equipment, IEC 61010, Implantable medical devices, SPE-3000 and more.

Global Regulatory Requirements

Critical information to effectively navigate Global Regulatory Requirements such as CB scheme, FDA requirements, ASCA, NMPA, Japan, Brazil, and more.

Connected and Digital Technologies

The latest information and expert resources regarding digital and connected medical technologies such as Software as a Medical Device (SaMD), Wireless devices, AI-Enabled and Machine Learning devices.

Performance Related Testing Solutions

Critical performance testing services to test and validate the quality of your Medical Devices, including battery testing, Reese’s Law compliance, testing for home healthcare environments, biocompatibility, reliability, benchmarking and more.

Sustainability Solutions and Services

Access to Assuris, our global network of scientists, engineers, and regulatory specialists providing support to navigate complex scientific, regulatory, environmental, health, safety, and quality challenges throughout the value chain.

Medical Device Testing and Scientific Support Services

Unrivaled expertise in Medical device materials testing, chemical analysis and scientific support.

Medical Device Materials Testing

Medical device materials testing services supporting the development, production and performance of medical devices and polymers, composites, multi-layer systems and metals.

Medical Devices Auditing and Certification Services

Auditing, performance, benchmarking and supply chain solutions to deliver insights and quality management into every aspect of your operations.

Intertek AI²

Intertek AI² enables organisations to power ahead with smarter, safer, trusted AI solutions.

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