Medical devices are one of the largest industries driven by new technologies so that continual innovation and speed to market define success. Our scientists have extensive backgrounds in applications and environmental effects on materials, as well as infection control technologies for reusable medical devices.
Throughout the product life cycle, we collaborate with your team to help navigate the complex regulatory process and help support your testing needs. Technical expertise in microbiology, chemistry, toxicology, virology, and molecular biology testing provides full-spectrum, single-source support to accelerate your time to market.
Microbac is ISO 17025-accredited, and GLP- and cGMP-compliant. We work with your company to adhere to the Quality System Regulation (QSR) and fulfill unique needs in medical device testing.
Focused on all aspects of product quality and safety, we can assist with validation in the following areas:
|Blood Glucose Monitoring System||High-Level Disinfectants for Endoscopes|
|Viral Barrier Test - Condoms & Sheaths||Treated Face Masks|
|Toxicology (ISO10993)||Antimicrobial Devices|
|Diagnostic Devices - 510(k)|