Nonclinical Testing

Overview

UL's worldwide network and complete portfolio of nonclinical testing services simplifies the process of acceptance in all your key markets by meeting all your test, regulatory and certification needs for global sales and distribution.

Definition

Nonclinical testing consists of laboratory testing (in vitro) performed on materials, end products and packaging for the primary purpose of verifying the biological, toxicological and mechanical safety prior to being studied on human subjects (in vivo).

Benefits

Safety has been UL's mission for over a century, and we have over 50 years of experience in physico-chemical, biocompatibility, toxicology, bioanalytical, microbiological, virological and pharmacology testing.

UL staff will work with you to assess the appropriate testing required and prepare a project plan tailored to your current and future product launch needs. This typically includes meeting with senior-level scientists experienced in preparing test protocols to meet regulatory submission requirements.

UL test facilities are accredited by an independent third-party to ISO 17025.


DELIVERABLES

Test Report for R&D, which can be used as part of the technical file submissions to regulatory bodies


PRODUCTS THIS SERVICE APPLIES TO

Inactive and active medical devices, pharmaceuticals, IVD devices, materials

APPLICABLE STANDARDS

EN ISO 10993 Series Series of standards for evaluating the biocompatibility of a medical device prior to a clinical study.
The United States Pharmacopeia (USP) Official pharmacopeia of the United States »

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