Quality

Bioscension Laboratory Services’ advanced quality control system assures you of test accuracy and high-quality results. Bioscension has state of the art certifications including ISO 17025 and ISO 11737.

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.

Our competency and the proficiency of our staff enables us to ensure that testing is accurate, efficient, reproduceable, repeatable, and reliable.

The Bioscension Lab is able to support your most critical business processes by catering to your consulting needs in terms of for example assistance with study/project planning, support with an FDA submission process, guidance on tested frequency and relative industry regulations: What testing does a client need? What organisms do they need to screen for? How often do they need to be testing their products or validating sterility?

ISO 11737

ISO 11737 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.

ISO 17025

ISO 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.

Bioscension Laboratory Services has a highly advanced quality system and has developed extensive material analysis and sample handling procedures.

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