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
Tired of waiting?
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
Cleaning Validation
Other
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
Cleaning Validation
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
Cleaning Validation
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.
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.
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.
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Have a question? Get in touch with us
