Rooted in excellence
CooperSurgical’s Commitment to Reaching Above and Beyond Industry Standards
We are rooted in a strong and ever-expanding network of experts dedicated to upholding the highest standards.
It is from this solid foundation that we renew our commitment to reaching new heights in quality assurance and innovation.
To honor this commitment, we are implementing a series of new standards and protocols throughout the various branches of our organization.
Use Case: Improved Media Testing for Increased Quality Control
New MEA Assays
For comprehensive evaluation.
Expert Assay Development Team
With our new in-house highly qualified QC development, we can maximize speed to market, a streamlined process and procedural oversights.
Chemistry Analyzers
Positively confirms component analysis.
Advanced Process Improvements
New additions to our QC and Lot Release procedures to ensure the highest quality standards
Laboratory Information Management System (LIMS)
Electronic Witnessing
Radio Frequency Identification (RFID)
Materials Management
Shining a Spotlight on MEA
- At CooperSurgical, we are implementing modifications to our MEA protocol to increase its sensitivity.
- The Mouse Embryo Assay, or MEA, is a vital tool for evaluating the developmental sub toxicities of various substances. By exposing mouse embryos to test media, we can assess their potential effects on embryonic development.
- The MEA process helps identify and/or quantify substances that may pose risks to fetal development, offering valuable insights for regulatory decisions.
- MEA plays a critical role in the approval processes for Assisted Reproductive Technologies (ART) media and devices.
- Regulatory agencies rely on MEA data to assess potential developmental risks and establish safety guidelines.
- Traditionally, MEA has been conducted through manual observations. However, this method can be prone to bias, as different operators may score embryos differently.
- This approach not only limits throughput but can also lead to inconsistencies in data interpretation.
- Owning the MEA protocol in-house allows for stringent oversight into processes and consistencies as well as ease of access to get answers for our customers.
Quality Control Measures
Standardized Testing Methods
- We’ve standardized our testing methods across families of media, which increases precision in results and reporting.
- Utilization of common equipment and procedures not only ensures the most accurate results, but improves our preventative maintenance, calibration, training, and certification programs for our dedicated staff.
Real-Time Data Analysis
- Incorporating LIMS allows real-time access to data, helping us extract meaningful insights regarding product consistency and performance outcomes.
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