Intertek Company Profile

Medical Device Testing and Certification

Get your device into the hands of your customers faster than ever before. Time to market starts with partnership, and for more than 50 years Intertek has been partnering with medical device manufacturers to develop global regulatory solutions for testing, certification and auditing. Our expertise helps you overcome regulatory difficulties and shorten your time to market. Our knowledge of standards speeds turnaround time in your certification process.

Regulatory Consulting Services

Find the results you’re looking for - consult with Intertek to develop a strategy that meets your compliance goals.

Safety Compliance Consulting
Whether you are seeking product-specific guidance or looking for an on-site Project Manager to become integrated with your team, we provide both long-term and short-term consulting solutions to meet your exact needs and help you get to market on time.

Risk Management Consulting
Meet regulatory requirements for risk management. Our medical device experts support you from the early stages of product development through certification, and beyond.

Market Research & Access
Develop global regulatory strategies with the support of our team. We conduct customized research to help you enter new markets with confidence.

FDA 510k Consulting
Gaining FDA clearance for your new medical device is no simple task. Fortunately, Intertek can lead the way to help you remove barriers and reduce complexity. 

Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.

Testing Solutions:  Safety,  EMC/EMI  and Performance Testing

Demonstrate compliance to electrical safety, EMC and performance standards. Reach your target markets quickly and cost-effectively with testing and certification for your medical device.

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

Wireless Device Technology
To evaluate your cutting-edge technology, rely on the capabilities and expertise of the industry’s leading medical EMC testing laboratory.Many portable medical devices incorporate wireless technology which may present risks for life-supporting equipment and other applications. To ensure compliance and prevent interference, you must validate your device to electromagnetic compatibility (EMC) standards. Intertek has the facilities and expertise to help you identify and understand the regulatory requirements applicable to your device, while managing your overall testing to relevant standards.

Embedded Software and Mobile Applications
Software validation is a vital tool used to assure the quality of medical device software and applications. Let us help you streamline the testing process, tighten up test plans or take on some of the testing when your team is overtaxed and up against a deadline.

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

Laboratory Equipment
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.

Batteries used in Medical Equipment
Reach global markets with compliance to IEC 62133 for lithium-ion batteries used in medical, IT and home healthcare equipment.

Active Implantable Medical...