Comprehensive Medical Device Testing and Certification
Ensuring your medical devices meet stringent safety standards while minimizing regulatory delays is crucial for success in today’s competitive landscape.
Eurofins MET Labs’ NRTL Listed MET Mark Certification provides a trusted pathway to global professional medical and home healthcare markets, streamlining the testing and certification process. Our comprehensive services and expertise enable you to navigate the complexities of regulatory requirements with confidence, ensuring your products meet the highest standards while accelerating time-to-market.
At Eurofins, we are not just testing – we are Testing for Life.
The Trusted Path to Global Markets
As the premier provider of testing and certification services, Eurofins MET Labs is uniquely positioned to support your medical device’s journey from concept to commercialization.
Our comprehensive service offerings include:
- Medical Device Safety Certification
- EMC Compliance
- Wireless Testing
- Environmental and Advisory Services
- Biocompatibility Studies
- Extractables & Leachables Studies
- Audit Services
- Medical Human Factors Studies
- Sustainability Services
Global Market Access with Unmatched Accreditation
We facilitate the launch of devices into the global market with the NRTL Listed MET Mark, backed by our A2LA ISO 17025 accreditation and approval in OSHA’s NRTL program. Our services are designed to meet the demands of regulatory authorities worldwide.
Standards and Regulatory Support
Our expertise spans a wide range of standards and regulatory submissions, ensuring your devices comply with:
- IEC/AAMI/CSA 60601-1 (Safety)
- IEC 60601-1-2, 4th ed. + Amendment 1 (EMC)
- FDA 510(k), PMA, and De Novo Submissions
- MDR EU/UK Notified and Certified Body Technical File Audits
- CB Scheme Certification
Why Eurofins MET Labs?
- Comprehensive Service Offerings Our partnership with INTERCO (IC) partners – EAG and BPT (Lancaster) – allows us to offer an extensive range of services that go beyond the traditional safety bench, performance, and EMC chamber. We cover the entire value chain in medical services, providing a one-stop solution for our clients.
- Innovative Collaborations Our organization is at the forefront of co-sharing marketing opportunities with IC partners to accelerate growth. Our collaboration with our cybersecurity partner Resillion on newly published medical standards – IEC/TR 60601-4-5 (Medical Security) and IEC 81001-5-1 (Health Software Security Life Cycle) – ensures we stay ahead in the industry.
- Respiratory Market Leadership The MET Labs facility in Irvine, California has quickly become the market leader in Ventilator & Humidifier testing, thanks to our investment and the reputation of our staff. We provide comprehensive testing services, including Safety, EMC, FDA Guidance, as well as VOCs and E&L testing.
- Accreditation and Standards Eurofins MET Labs A2LA ISO 17025 accredited, covering over 90 medical collateral and particular standards across all major device categories such as Home Healthcare, Medical Monitoring, Respiratory, Laser, Imaging, and more.
- Expertise and Support Our team of Subject Matter Expertize is second to none. They provide invaluable assistance with white papers and guidance documents, ensuring our clients have access to the latest and most reliable information in the industry.
Our commitment to excellence and innovation is why we lead the way in the medical manufacturing market. Discover how Eurofins can be part of your journey to excellence.
