Medical Device Compliance Solutions for Safety and EMC Standards

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

Intertek provides expert safety testing and electromagnetic compatibility (EMC) solutions, helping medical device manufacturers meet critical global standards with greater efficiency, speed, and confidence. From design to market entry, our services ensure compliance with IEC 60601-1, IEC 60601-1-2, and other key regulations for safety, EMC, and medical device performance.

With expertise in medical imaging technologies, implantable devices, home healthcare equipment IEC 61010 for laboratory equipment and much more, we address the unique challenges of modern medical innovations. Our advanced facilities and experienced engineers provide reliable testing that ensures your devices meet the highest standards of safety, performance, and reliability.

Intertek helps you navigate complex compliance requirements and accelerate time to market, delivering confidence that your devices perform safely in real-world environments. We are your trusted partner to bring innovative, compliant, and high quality medical solutions to the global healthcare market.

IEC 60601: Product Safety Standards for Medical Devices

End-to-end solutions from product development and risk management file reviews to comprehensive testing to the IEC 60601-1 series.

IEC 60601-1-2: Medical Device EMC Testing

IEC 60601-1-2 Electromagnetic Compatibility (EMC) Testing for Medical Devices including IEC 60601-1-2 4th Edition Amendment 2.

Home Healthcare Equipment Testing and Certification

Comprehensive Testing and Certification solutions for Home Healthcare Equipment to all applicable standards including IEC 60601-1-11.

Medical Imaging Equipment Testing

Expert Medical Imaging Equipment Testing and Certification solutions ensuring your medical imaging equipment meets all applicable safety requirements.

Biocompatibility Testing and Evaluation

Unrivaled capabilities in Biocompatibility Testing and Evaluation for medical devices, delivering comprehensive solutions aligned with ISO standards to ensure safety and compliance.

ISO 18562 and VOC Testing for Medical Devices

The industry leader in ISO 18562 and VOC Testing and Evaluation solutions of breathing gas pathways in medical devices with comprehensive expertise and solutions.

IEC 61010: Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use

Critical information on IEC 61010, the standard for testing Medical Laboratory Equipment, to ensure your products remain in compliance with the latest revision of IEC 61010.

Implantable Medical Devices Testing Solutions

Guidance on innovative Implantable Medical Devices such as Cochlear Implants, monitoring devices, pacemakers, etc. to comply with safety, EMC and product-specific standards.

Ventilator Production & Testing

Immediate Ventilator Testing assistance for manufacturers along with regulatory requirement guidance for safety, performance, labeling and more.

SPE-3000: Medical Field Evaluations

For medical products entering the Canadian market, SPE-3000 serves as the model code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES), specifically pertaining to safety from electric shock, fire and mechanical hazards.