Services

Medical Devices

Bioscension offers comprehensive testing services for medical device companies and healthcare facilities:

Device Tests:

Cleaning validation
Disinfection validation testing
Disinfection efficacy
Zone of inhibition
End-of-life testing
Endoscope sampling kit
Scope processing validations
Soiling, inoculating

Biocompatibility and Toxicology:

Irritability
Sensitization
Cytotoxicity

Sterility Assurance:

Antibiotic potency test
Bacterial endotoxins test
Biological indicators
EO sterilant residual test
Microbial identifications
Particulate matter
Product bioburden
Product sterility
Radiation audits
Standard plate counts

Sterility Validation:

Filter sterilization validations
Product inoculations

510(k) Clearances

Our consultants have deep and broad experience in 510(k) submission and have participated in achieving 50+ FDA clearances. Bioscension can provide needed test services, regulatory guidance, and process support

Monitoring

Bioscension offers testing and monitoring services to ensure your facility meets important quality control standards.

Disinfection efficacy studies
Environmental monitoring testing – air and water
Filter sterilization validations
Forced degradation material

Material characterization screens of raw materials
Residual manufacturing materials
Water system validation and monitoring

Water management services – When Auditors Ask About Water Quality—What Will Your Data Show?

Joint Commission surveys increasingly expect facilities to demonstrate control over water systems supporting sterile processing. With Bioscension, water quality monitoring is documented, trended, and aligned with ANSI/AAMI ST108, providing clear evidence of oversight, risk management, and continuous improvement. ANSI/AAMI ST108 defines water quality categories, monitoring frequency, and performance expectations. Bioscension provides the tools, expertise, and laboratory support needed to execute and sustain a compliant monitoring program.