Quality by Design: Transforming IVD Manufacturing
Embedding Quality Early in the Process vs Quality Checks at the End
Quality by Design (QbD) is revolutionizing In Vitro Diagnostics (IVD) manufacturing by placing emphasis on quality throughout the entirety of product development. QbD employs a more sophisticated, risk-centric approach to end-product testing. As a result, the reliability of the product, the efficiency of the design and the development process, the compliance to regulations, and the ultimate beneficiary of the product, the patient, all experience enhanced outcomes.
Have a look at our exclusive infograph to learn about the QbD principles that are enabling IVD manufacturers to improve the speed of product development.
The Significance of Quality by Design
As the need for more and better diagnostic tools continues to grow, the application of Quality by Design in IVD manufacturing has become critical. QbD allows manufacturers to define critical quality attributes and process parameters early in the product development lifecycle. This assists manufacturers in reducing variability and eliminating the risks associated with production prior to actually starting the manufacturing of the product for commercial distribution.
Manufacturers are now able to leave behind traditional methods of end-product quality assurance that are more passive, and adopt methods of active quality assurance that are more comprehensive, ensuring better products.
What You Will Find
This infograph shows:
Foundational elements of Quality by Design within IVD manufacturing
Improvement of yielded products and processes through QbD
Essential steps in a QbD system
Importance of risk assessment and design space
Understanding and meeting regulatory requirements
Positive impact on manufacturing, healthcare, and patient outcomes
Maintaining quality during development and implementing strategies to improve speed
Why Download the Infograph?
Quality by Design is proving to show more flexible, advanced, and compliant views on IVD manufacturing design. This will allow design teams to consider product quality, flexibility and compliance mitigating diagnostic risk in a global health context.
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