Medical Device Testing
For more than 20 years, Microtest has been a leader in medical device testing services, as well as medical device package testing. The company’s renowned problem-solving approach provides numerous advantages, including
• Reduced cost
• Low or no risk
• Rapid regulatory approvals
• Faster time to market
• Greater customer control of testing
• Minimal lab excursions, out-of-spec tests, and schedule disruptions
 Also, our expanding pharmaceutical division provides efficient synergies for clients with medical devices containing pharmaceuticals. For example, these combination products include drug-coated stents.
Our facilities are ISO 9001-certified and U.S. FDA-regulated, meeting all GLP/GMP standards. A recent $7.5 million capital improvement program included state-of-the-art sterility suites and a MicroSeq microbial identification system. And our labs are staffed by highly educated, trained, experienced people. Result: an unmatched combination of knowledge and technology.
Microtest helps medical device manufacturers provide safe, high-quality products. And we do it fast, with maximum cost-effectiveness.
Medical Device Testing Services
Gamma/ethylene oxide (EO) sterilization validation
• Bioburden
• Bioburden recovery
• Bacteriostasis/fungistasis
• Sterility
• EO residuals
• Spore strip population
Reusables
• High/low-level disinfection
• Cleaning studies
• Steam/EO/chemical sterilization
Endotoxin
• FDA/USP gel clot
• Chromogenic
• Turbidimetric
Sterility
• USP
• Product immersion
• Product flush
• Biological indicator
• Membrane filtration
Related services
• Biocompatibility/toxicology
• Environmental monitoring
• Medical Device Package Testing - stability and validation
• Bacterial & fungal identification services
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