Medical Device Testing | Medical Device Laboratory Testing Solutions

Medical Device Laboratory Testing Solutions

Each year millions of Americans depend on Nova. Since 1993, Nova Biologicals, Inc. has been a leader in medical device testing services. Nova is an FDA and EPA, GLP Microbiology Laboratory. Nova's Quality Assurance Plan and processes meet the requirements of our clients with GMP, ISO, and FDA manufacturing conditions. Nova is FDA registered (Registration Number 1641521) and is designated by the FDA as a private laboratory and complies with the FDA's GLP and GMP requirements. Nova is certified by the U.S. EPA's National Environmental Laboratory Accreditation Program (NELAP) and TDSHS (TDH) and participates in proficiency testing programs established by MicroCheck.

Sterilization Validation

Bioburden
Bioburden Recovery
Bacteriostasis/Fungistasis
Sterility, USP <71>
Endotoxin/LAL/Pyrogen, USP <85%>
Spore-strip Population Verification

Sterility USP <71>

Product Immersion
Product Flush
Biological Indicators 3, 5, and 7 Day Hold
Membrane Filtration
Growth Promotion
Bacteriostasis/Fungistasis
Organism Identification

Environmental Monitoring

Temperature
Relative Humidity
Particle Count Surveys
Viable Microbe Surveys
Organism Identification
Clean Room Disinfection Validation

Endotoxin USP <85>

Gel Clot
Chromogenic
Turbidimetric

Reusable Medical Devices

Cleaning Validation Studies
Disinfection Validation Studies
Sterilization Validaiton Studies

GLP Studies

FDA 510K Application Testing Services
Study Design and Protocols
Data Collection
Data Management
Document Control

Antimicrobial-Impregnated Medical Devices

Antimicrobial Efficacy AOAC
Antimicrobial Effectiveness, USP <51>
Neutralization Validation
Zone of Inhibition
Susceptibility Testing
Minimal Inhibitory Concentration
Minimal Bactericidal Concentration
Extensive in-house Organism Library including