Your Bioscience Partner

Bioscension Laboratory Services is a state-of-the art bioscience lab, focused on supporting advanced, emerging medical device companies with high-quality testing, monitoring, and consulting services.

High testing quality based on reliability and
reproducibility of validated methods

Bioscension Laboratory Services provides high-quality, reproducible, and strategic bioanalytical testing services and compliance/validation solutions for single-use medical devices and repackaged medical devices via competent and trained staff, appropriate equipment and processes, and the support of Senior Management. Bioscension Laboratory Services will meet or exceed customer and external requirements while maintaining the effectiveness of its Quality System.

All you need to file a 510(k) – and more

  • Our specialized bioscience offering is designed to help you quickly get the results you need to support your core business processes.

Tired of waiting?

  • Demand for lab services is growing rapidly, due to demographics, heightened regulatory requirements, and increasing R&D spend and innovation. One of the consequences has been pent up demand, increasing prices, and long wait times. Bioscension Laboratory Services is committed to short turn-around times.

Quality Matters.

  • Bioscension’s advanced quality control system assures you of test accuracy and high-quality results

  • State of the art certifications including ISO 17025 and appropriate material analysis and sample handling procedures

Benefits

Bioscension Laboratory Services are next generation testing, monitoring and consulting services for advanced medical device companies.

Fast turn-around
Time

Affordable
Prices

ISO
Certification

Strong Quality
System

High Quality
Testing

Advanced Bioscience
Staff

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

  • Microbial Identification

Cleaning Validation

  • Protein

  • Hemoglobin

  • Total Organic Carbon

Other

  • Exhaustive Recovery Efficiency (ERE) studies

  • Inhibitory substance screening

  • Microbial Identification & Sequencing

  • Bacteriological Indicator Population Verification

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

  • Microbial Identification

Cleaning Validation

  • Protein

  • Hemoglobin

  • Total Organic Carbon

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

  • Microbial Identification

Cleaning Validation

  • Protein

  • Hemoglobin

  • Total Organic Carbon

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.

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.

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.

A changing medical device industry

Advanced medical device firms are emerging in the US economy focused on new technologies, sustainable designs, and sophisticated bioscience solutions. Bioscension Laboratory Services provides state-of-the art lab services to match these developments.

Want more from Bioscension?

Have a question? Get in touch with us