Medical Devices

Medical device product safety testing, certification, and evaluation for global approvals.

Your partner for medical device testing, certification, and global market access.

The medical industry is rapidly adopting new technology which enables better communication and performance of products and systems to improve patient safety.

Electronic devices used in medical environments have important safety and performance requirements to ensure safety and compatibility with other critical care equipment. These devices also need to reduce unacceptable risk to patients.

As a result, medical device regulations continuously change leaving manufacturers to face a number of compliance challenges.

Eurofins E&E North America is a one-stop-shop for electrical product safety, electromagnetic compatibility (EMC), RFID susceptibility, and FDA submissions for medical devices to verify compliance with major standards including 60601, ISO 14708, and international regulations.

As part of the Eurofins E&Enetwork of testing laboratories, we can meet all your medical device product safety testing needs.

Get your medical device to market faster and easier with Eurofins E&E North America. We are the very first NRTL, a leading National Certification Body (NCB), and a CB Testing Laboratory (CBTL) in the IECEE CB scheme.

Why Eurofins E&E North America?

Our Medical Device Safety Testing services

With more than 100 years of product safety and electromagnetic compatibility expertise, Eurofins E&E North America and Eurofins Medical Device Testing can collaborate to help you navigate complexities in medical device compliance. From testing & certification to global market access, we help you bring your product to market faster and more cost-effectively. As part of the Eurofins E&E global testing network, we can provide an end-to-end solution for all of your testing and compliance challenges.

• Medical Device Safety Testing
• Comprehensive Medical Device Testing Services
• IEC 60601-1 Testing
• Medical Device EMC Testing
• Eurofins E&E Notified Body (EU) Certification Services
• FDA Submissions
• Laser Safety Testing
• Battery Testing & Certification

Benefits of working with us

Global Leader in Medical Device Testing

The MET NRTL mark is the first ever to be officially recognized by OSHA for workplace safety. As a trusted partner in the industry, we offer regulatory compliance expertise and experienced ISO 17025 testing to ensure rapid turnaround times with the highest level of service for active medical devices/electrical equipment.

Single-Source for Medical Device Certifications

We provide the full range of medical device product safety testing per the 60601-1 standard family. We also offer complete testing for active implantable devices. Our state-of-the-art 3, 5, and 10-meter EMC chambers are equipped to evaluate your medical device to global EMC and Wireless regulatory requirements. Our FDA submission services ensure your submission will meet FDA requirements, and your product launch will not be delayed.

Testing & Certification for Worldwide Market Access

We can provide testing and technical reports which can be used to support a manufacturer's Declaration of Conformity (DoC) for CE marking. Together with Eurofins Medical Device Testing, we work with product designers and manufacturers to certify products under several annexes of the Medical Device Directive (MDD). Our Notified Bodies are authorized to issue Type Certificates for active and non-active medical devices in accordance with the Medical Device Directive.

Our Medical Device Testing & Certification Capabilities

Our thorough knowledge of industry performance and national safety standards and extensive global testing and certification resources, allows for swift and cost-effective market entry.

• Product Safety Testing & Certification of Active Medical Devices
• Electromagnetic Compatibility (EMC) of Active Medical Devices
• Laser Safety Testing of Medical Laser Products Per IEC 60601-2-22
• FDA Submissions
• Battery Safety Testing of all Battery Chemistries used to Power Medical Equipment
• RFID Susceptibility of Active Medical Devices
• Certification Body (NCB) & Certification Body Testing Laboratory (CBTL) certification for Medical Electrical products
• Inspections of high-end medical equipment (e.g. MRI and CT scanners) in hospitals

What is Medical Device Testing?

Medical device safety testing consists of a series of specific tests which are performed to certify that a product will not suffer from interference in the applicable medical environment and will prevent unacceptable risks to patients.

The manufacturer also performs a risk assessment and submits that assessment to the test laboratory in the form of a risk management document. This document provides evidence that a manufacturer has considered all potential hazards and mitigated associated risks to the highest degree possible.

The general medical device safety testing requirements for most electronic medical devices can be found inside the IEC 60601 standard family.

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