Testing

Bioscension offers all the testing services needed for an FDA 510(k) clearance.

Bioburden

  • Bioburden testing (Enumeration/estimation)

  • Sterility testing (Absence/presence)

  • Microbiological monitoring activities (surface, equipment or environment testing)

  • Inoculated Product Recovery Efficiency (IRE) Studies

  • Fourier Transform Infrared Spectroscopy (FTIR)

  • Gas Chromatography/Mass Spectrometry (GC/MS) testing

  • Gram/spore staining

Cleaning Validation

  • Protein

  • Hemoglobin

  • Total Organic Carbon

Other

  • Exhaustive Recovery Efficiency (ERE) studies

  • Inhibitory substance screening

Process

We collect medical device product samples from batches of manufactured or reprocessed medical devices and process them in a sterile environment within our microbiology laboratory to provide a cost effective, reproducible and reliable bioburden estimates for the device/product samples. The samples are prepared according to standard microbiological procedures taking in account sample volume,  dilutions, plating methods/parameters, and incubation parameters. The plates are enumerated and a final report is generated for the particular sample based on the clients requirements and specifications.

Testing

Bioscension offers all the testing services needed for an FDA 510(k) clearance.

Bioburden

  • Bioburden testing (Enumeration/estimation)

  • Sterility testing (Absence/presence)

  • Microbiological monitoring activities (surface, equipment or environment testing)

  • Inoculated Product Recovery Efficiency (IRE) Studies

  • Fourier Transform Infrared Spectroscopy (FTIR)

  • Gas Chromatography/Mass Spectrometry (GC/MS) testing

  • Gram/spore staining

Cleaning Validation

  • Protein

  • Hemoglobin

  • Total Organic Carbon

Other

  • Exhaustive Recovery Efficiency (ERE) studies

  • Inhibitory substance screening

Consultation

In addition to tests, Bioscension offers consultation in terms of what testing you need, what organisms do you need to screen for, how often do you need to be testing your products or validate sterility?

Testing

Bioscension offers all the testing services needed for an FDA 510(k) clearance.

Bioburden

  • Bioburden testing (Enumeration/estimation)

  • Sterility testing (Absence/presence)

  • Microbiological monitoring activities (surface, equipment or environment testing)

  • Inoculated Product Recovery Efficiency (IRE) Studies

  • Fourier Transform Infrared Spectroscopy (FTIR)

  • Gas Chromatography/Mass Spectrometry (GC/MS) testing

  • Gram/spore staining

Cleaning Validation

  • Protein

  • Hemoglobin

  • Total Organic Carbon

Other

  • Exhaustive Recovery Efficiency (ERE) studies

  • Inhibitory substance screening

Test submissions for Bioscension

Please complete the appropriate form and submit it with your testing order. This enables us to expedite your test process with minimal or no delays.

If you are shipping hazardous materials, please take appropriate steps.

Testing

Bioscension offers all the testing services needed for an FDA 510(k) clearance.

Bioburden

  • Bioburden testing (Enumeration/estimation)

  • Sterility testing (Absence/presence)

  • Microbiological monitoring activities (surface, equipment or environment testing)

  • Inoculated Product Recovery Efficiency (IRE) Studies

  • Fourier Transform Infrared Spectroscopy (FTIR)

  • Gas Chromatography/Mass Spectrometry (GC/MS) testing

  • Gram/spore staining

Cleaning Validation

  • Protein

  • Hemoglobin

  • Total Organic Carbon

Other

  • Exhaustive Recovery Efficiency (ERE) studies

  • Inhibitory substance screening

Bioscension’s Commitment

We understand that testing often involves long wait times – and you don’t always have time to wait. Therefore, we have designed a process that enables us to return results to you faster than other testing services companies without loss of accuracy.

Monitoring

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

  • Water monitoring (LAL testing)

  • Environmental monitoring (cleanroom setup)

Monitoring services from Bioscension

Please complete the appropriate form and submit it with your testing order. This enables us to expedite your test process with minimal or no delays.

If you are shipping hazardous materials, please take appropriate steps.

Monitoring

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

  • Water monitoring (LAL testing)

  • Environmental monitoring (cleanroom setup)

Bioscension’s Commitment

We understand that testing often involves long wait times – and you don’t always have time to wait. Therefore, we have designed a process that enables us to return results to you faster than other testing services companies without loss of accuracy.

Consulting

Bioscension staff can support your FDA – 510(k) – clearance process.

  • Data analysis

  • FDA/responses/interaction

  • Test development

  • 510(k) process

  • Methods to extract bioburden

Bioscension Consulting

Bioscension staff have received more than 50 FDA clearances over the past 10 years – for new, advanced types of medical devices.

Properly handling FDA interaction is the key to a faster, more successful clearance process.

Our consultants can support this.

Consulting

Bioscension staff can support your FDA – 510(k) – clearance process.

  • Data analysis

  • FDA/responses/interaction

  • Test development

  • 510(k) process

  • Methods to extract bioburden

ISO/IEC 17025

ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world

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