Medical Devices

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, molecular biology and physical 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:

  • Microbiology: antimicrobial efficacy and cleaning/disinfection validation
  • Chemistry: raw material testing and verification
  • Virology: viral clearance, viral inactivation and viral claim support
  • In-vitro Toxicology: bench and clinical studies to ensure product is safe for human use
  • Physical: materials compatibility, failure analysis and package strength and integrity

 

Review testing packages for your next project >