Demonstrate Compliance to Electrical Safety, EMC and Performance Standards for Medical Devices

We know a faster launch means more immediate access to life-saving technology and at Intertek, we’re committed to clearing a path to market for your latest innovation. With Intertek as your partner, you can navigate the mandatory requirements for electrical safety and deliver your product into the hands of healthcare professionals, patients, and caregivers faster than anyone else in the industry. That means shorter time to revenue generation and increased profitability for your organization.

FDA ASCA Program

The FDA's ASCA Program is aimed at ensuring quality and accuracy in medical device pre-market submissions. Ultimately the goal is to help make the process more efficient and to add confidence in the levels of safety, performance, and quality assurance.

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.

Wireless Technology in Medical Devices

Intertek offers comprehensive Wireless Testing services for Medical Devices including performance, security and privacy solutions helping you to market faster.

Performance Testing for Medical Devices

Intertek offers a wide scope of custom Performance Testing services for Medical Devices that help manufacturers assess risk and avoid costly field failures

Medical Imaging Equipment Testing

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

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

Battery Safety Testing for Medical Devices

Intertek provides Battery Safety Testing to the Requirements of IEC 62133 for Medical Devices throughout global markets with over 50 years of experience.

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

Software Validation and Mobile Applications Testing for Medical Devices

Intertek offers Software Validation and Mobile Applications Testing solutions for Medical Devices which are vital tools used to assure enhanced quality and performance.

Unique Device Identification (UDI) Compliance Services

Leverage Intertek’s expertise in Unique Device Identification (UDI) Compliance solutions to navigate the complexities of UDI compliance and to ensure your medical devices are compliant, traceable, and safe.

Related Links

Q&A: Sustainable Innovation in Medical Device Manufacturing

The need for manufacturers to incorporate sustainable practices into their operations and product development has never been more pressing. Intertek's Q&A explores ways medical device manufacturers can integrate sustainability into their products and organizations.

*The Intertek legal entities that provide medical device management system certification services (including ISO 13485 and MDSAP) and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) do not provide any consulting services. Clients who have used other Intertek legal entities’ consulting services are not eligible to receive management system certification services or Notified Body services from Intertek.

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