Intertek supports Medical Device manufacturers in meeting all Safety and Quality requirements around the world
Simplifying the complex world of medical device compliance requires a trusted partner with unparalleled expertise. Intertek is committed to helping you bring innovative and high-quality medical devices to market efficiently and confidently.
We offer comprehensive medical device assurance, testing and certification solutions designed to meet stringent regulatory requirements, including FDA guidance, 60601-1 standards, and other global standards. Our services ensure your devices not only comply with the latest safety and performance regulations but also gain faster market entry to every region around the world.
From electrical safety and EMC to cybersecurity, biocompatibility and beyond, our experts are well-versed in the challenges of today’s medical device regulatory and compliance landscape. Whether you’re developing never-before-seen technologies or improving existing FDA-approved medical devices, Intertek provides the assurance you need to succeed.
Intertek's Solutions for Medical Devices
State of the art Standards for Safety and EMC
Intertek offers solutions for state of the art safety testing and EMC requirements, including IEC 60601-1, 60601-1-2, Home Healthcare, medical imaging equipment, IEC 61010, Implantable medical devices, SPE-3000 and more.
Global Regulatory Requirements
Bring your Medical Device to market with a partner who can help you navigate Global Regulatory Requirements such as CB scheme, FDA requirements, ASCA, NMPA, Japan, Brazil, and more.
Connected and Digital Technologies
Innovation in Medical Devices largely centers around digital and connected technologies such as Software as a Medical Device (SaMD), Wireless devices, AI-Enabled and Machine Learning devices.
Performance Related Testing Solutions
Test and Validate the Quality of Your Medical Devices with Performance Testing, including battery testing, Reese’s Law compliance, testing for home healthcare environments, biocompatibility, reliability, benchmarking and more.
Sustainability Solutions and Services
Intertek Assuris provides a global network of scientists, engineers, and regulatory specialists providing support to navigate complex scientific, regulatory, environmental, health, safety, and quality challenges throughout the value chain.
Medical Devices Auditing and Certification Services
The medical device industry faces specific challenges when bringing their products to the global market with strict and complex global regulations. Our Auditing and Certification Services offer a unique combination of in-depth knowledge and global presence.
Medical Device Testing and Scientific Support Services
Medical device materials testing, chemical analysis and scientific support.
Clinical Studies
Multi-disciplined clinical teams who provide robust, GCP and ISO 14155 compliant clinical trials.
Knowledge Center
Download the latest information from our medical device compliance experts
Creation of IEC 60601-1 4th Edition
IEC 60601-1-2 Ed. 4.1 Overview of Requirements
Medical OEM Wireless Coexistence Testing
Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices
Biocompatibility Risk Assessment and Evaluation Plans
For more expert papers, recordings, and presentations, visit our Medical Resources hub.
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** 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.