Testing & validation

Testing and validation are critical steps in ensuring the safety, efficacy, and quality of orthopedic implant solutions. At Croom Medical, we offer a comprehensive suite of testing and validation services, including mechanical testing, materials analysis, and performance testing. Our team of experts conducts installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for new equipment and processes. We also utilise Design Failure Mode and Effects Analysis (DFMEA) to identify potential failures and mitigate risk throughout the product development process. With our rigorous testing and validation protocols, OEM customers can have confidence in the safety and effectiveness of their orthopedic implant solutions.


Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) are critical components of testing and validation to ensure the safety and efficacy of our orthopedic implant solutions. IQ ensures that equipment is installed correctly and according to specifications, OQ verifies that the equipment operates correctly, and PQ ensures that the equipment produces the desired results. Our team of quality professionals follows industry standards to develop and execute comprehensive testing and validation protocols that cover IQ, OQ, and PQ for new equipment and processes. These protocols enable us to identify and mitigate risks, ensuring that our products meet the highest quality and compliance standards.

Design failure mode and effects analysis (DFMEA)

Design Failure Mode and Effects Analysis (DFMEA) is a critical tool used in the product design and development process. It allows us to identify potential failure modes and their effects on the product or system being developed, as well as the causes of those failure modes. This enables us to implement design changes and risk mitigation strategies to ensure the highest level of product performance and reliability. Our team of experts uses DFMEA as part of our comprehensive approach to quality assurance and risk management throughout the product development lifecycle, ensuring that our products meet or exceed the highest standards of safety and efficacy.

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Process transfer & validation

At Croom Medical, we understand the importance of a seamless and efficient process transfer when working with OEM partners. Our team of experienced professionals work closely with our customers to ensure that their processes are smoothly integrated into our manufacturing operations. We provide full process transfer support, including IQ, OQ, and PQ to ensure that our customers’ processes meet the same high standards of quality and compliance as our own. Our commitment to continuous improvement and collaboration means that we are always looking for ways to streamline the process transfer process, reducing costs, and improving lead times for our customers.