Medical Devices Testing Solutions

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 Pilot Program
Learn more about the FDA's new voluntary program for medical device testing known as "ASCA" (Accreditation Scheme Conformity Assessment) and Intertek's participation in the program

IEC 60601-1-11: Home Healthcare Equipment
Does your medical equipment comply with the new standard for home healthcare? Certify your product to IEC 60601-1-11 requirements.

Wireless Technology in Medical Devices
To evaluate your cutting-edge technology, rely on the capabilities and expertise of the industry’s leading EMC testing laboratory.

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

Imaging Equipment
Get your latest innovation to market faster with testing and certification to IEC 60601 standards for medical imaging equipment.

IEC 61010: Medical Laboratory Equipment Testing
Meet IEC 61010-1 compliance deadlines with guidance and testing support from our global team of engineers specializing in medical, laboratory, and test & measurement equipment.

IEC 62133: Battery Safety Testing for Medical Devices
Reach global markets with compliance to IEC 62133 for lithium-ion batteries used in medical, IT and home healthcare equipment.

Active Implantable Medical Devices
Verify that electrical and environmental impacts pose no effect to your implantable device with electrical safety and EMC compatibility testing.

Embedded Software and Mobile Medical Applications
Lack internal resources to validate software or test mobile apps across the many smartphones in the global market? Our specialists will quickly help you validate your software and mobile applications.

 

 

*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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