The expanding scope of medical device testing
Medical product safety, performance and quality paradigms are shifting as devices become more interoperable, hospital environments become more complex and digital health technologies proliferate. Only through third-party testing and certification can manufacturers demonstrate claims of safety, quality and performance for their products, even as they innovate.
Leverage our rigorous testing and certification capabilities
Demonstrate device safety and performance
Meet regulatory requirements and industry standards to deliver robust devices.
Meet market access requirements
Use testing and certification results to address regulatory requirements.
Demonstrate electromagnetic compatibility (EMC)
Meet EMC regulations and mitigate risks of electromagnetic interference.
How we help customers deliver safe and compliant products
Medical Device Performance and Safety Testing
We conduct independent, rigorous testing and certification of medical devices to help manufacturers demonstrate safety and performance claims according to regulatory requirements and industry standards.
Medical Device EMC Testing and Certification
In environments where electromagnetic interference poses risks to patients, we provide electromagnetic compatibility (EMC) testing and certification to help demonstrate conformance to the IEC 60601-1-2 standard for safety and essential performance.
Medical Device Biocompatibility Testing
For wearable or implantable medical devices, we provide toxicity and biocompatibility testing to help support safety and performance claims according to the ISO 10993 standard as well as requirements from regulators.
Medical Device Packaging Testing
We offer medical device packaging validation and stability testing according to standards such as ISO 11607-2:2019 for packaging terminally sterilized medical devices. Our testing covers seal integrity, sterility, qualification of packaging materials, air permeability and more.
Restricted Substances Testing and Advisory Services
Our testing and advisory services help customers demonstrate compliance to requirements such as the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Restriction of Hazardous Substances (RoHS) regulations.
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Meet our experts
“Together, we create solutions that help Medtech innovators ensure essential technologies reach the market safely and effectively.”
Pamela K. Gwynn
Principal Engineer, Consumer, Medical and Information Technology (CMIT)
Featured resource
U.S. Market Access for Medical Devices: FDA and ASCA Program 2024
Our on-demand webinar covers the U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program to boost confidence in device testing.
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