State of the Art Safety and EMC Standards Testing and Solutions

Intertek provides state of the art 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

We offer end-to-end solutions from product development and risk management file review/documentation, to comprehensive testing to IEC 60601 series of standards.

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 1.

Home Healthcare Equipment Testing and Certification

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

Medical Imaging Equipment Testing

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

Biocompatibility Testing and Evaluation

Intertek is an industry leader 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

Intertek is committed to providing expert 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

IEC 61010 is the standard for testing Medical Laboratory Equipment. Ensure your products remain in compliance with the latest revision of IEC 61010 with Intertek

Implantable Medical Devices Testing Solutions

Intertek can help Implantable Medical Devices such as Cochlear Implants, monitoring devices, pacemakers, etc comply to safety, EMC and product-specific standards

Ventilator Production & Testing

Intertek can provide 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.

SATELLITE™ Client Test Program For Medical Devices

Intertek’s SATELLITE™ Client Test Program revolutionizes compliance for medical device manufacturers, giving you the ability to perform testing in your own facilities while maintaining adherence to critical standards like IEC 60601-1, 60601-1-2, and IEC 61010

Preliminary Design Reviews For Medical Devices

Our Preliminary Design Review (PDR) services are tailored to the unique challenges of medical devices, including complex component integrations and evolving regulatory landscapes.