Give your device a healthy start
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50+ years of cumulative microbiology experience
In-lot release programs include testing to confirm sterility, the absence of bacterial endotoxin and device bioburden levels
Tailored design for successful global submission
Microbiology testing of medical devices involves identifying the presence and risk of microbial contaminants. If not properly addressed, microbial contamination can cause serious threats to both personal and public health.
When you need to develop an effective microbiological testing strategy, count on our decades of experience. We’ll customize the right microbial assessments for your product that fulfill regulatory requirements. All of our studies are backed by a complete documentation package and are performed with a focus on quality with quick turnaround times.
Our testing portfolio covers reusable device validations, packaging integrity testing, manufacturing support testing, antimicrobial/preservative testing effectiveness, microbial ingress or in-lot release assays including presence of bacterial endotoxin, sterility assurance and bioburden levels. You’ll find Labcorp has the specialized knowledge, resources and capabilities to deliver strategic microbiology testing solutions that move your device or combination product forward.
We know that your medical device or combination product has the potential to bring greater outcomes to patients in need. That’s why we share your urgency to advance your medical devices and combination products. Whatever your goals and milestones, we’ll help you reach them on time. From developing clear road maps to communicating proactively, we work with speed and efficiency at every turn to keep pace with your important milestones.
