Non-Clinical Testing Solutions for Medical Devices

UL Solutions is a leader in non-clinical testing and provides testing and toxicology services for manufacturers to help demonstrate compliance for medical devices and accessories.

We can help you identify necessary testing and compliance requirements in advance to help navigate the information required for U.S. Food and Drug Administration (FDA) 510(k) clearance and notified body review, minimizing costly delays that impact time to market.

The regulatory approval process for medical devices is complex and not always well-defined. The FDA is the federal agency responsible for the regulatory oversight of medical devices in the U.S. Most medical device premarket reviews conducted by the FDA fall under its 510(k) Premarket Notification program. In addition to the device description, equivalent devices, software and performance testing information, the FDA 510(k) submission must include data regarding the biocompatibility of any patient contacting materials, directly or indirectly, next to other applicable data derived from non-clinical testing.

Many regulatory submissions provide inadequate information regarding device biocompatibility or fail to provide any biocompatibility data at all. Additional information requests add time to the review process, which affects your time to market.

Completing the required testing and toxicological risk assessments in advance may help with U.S. FDA or notified body clearance, minimizing delays that will affect your time to market.

Testing services for medical devices

UL Solutions’ non-clinical testing methods are validated and accredited per ISO/IEC 17025. Where applicable, we offer compliance with Good Laboratory Practices (GLP). Our scientists, toxicologists and engineers rigorously test healthcare products and their packaging for customers around the globe for both safety and compliance.

We can assist you with:

• ISO 10993-1 – Planning the biological evaluation for your medical device
• ISO 10993-1 series of standards – Biocompatibility testing and evaluation
• ISO 10993-18 – Chemical characterization and physiochemical analysis for direct or indirect body contact
• ISO 10993-17 – Toxicological risk assessment
• ISO 11607 series of standards – Packaging safety of terminally sterilized medical devices, including testing related to qualification (IQ/OQ/PQ), shelf-life (stability) and transport (performance)
• ISO 17664 series of standards – Processing validation for re-usable medical devices for critical, semi-critical and non-critical devices
• FDA Guidance – Reuse life cycle testing
• Microbiological test methods, bacterial endotoxin and particle testing

Why UL Solutions

We offer a full range of medical device testing services to support your needs. From design to aftermarket, our scientists and toxicologists can help you demonstrate safety and mitigate the risk for your medical devices.

Evaluation is one of the key steps in the medical device life cycle, and we can help you evaluate your medical devices in accordance with national and global standards. Our familiarity with these standards makes for a seamless and trustworthy evaluation process.

• We have a strong team of professionals in diversified domains, building on our 25 years of expertise in non-clinical medical device testing.
• We have experience working with multiple regulatory bodies worldwide.
• Our senior toxicologists are American board-certified.
• Our scientists participate in developing the standards related to ISO 10993, ISO 18562 and more.
• We have a presence in more than 100 countries.