Services

At Croom Medical, we believe that providing advanced manufacturing capabilities is only part of what it takes to be a leader in the orthopedic implant industry. That’s why we also offer a range of additional services and solutions to support our OEM customers throughout the product lifecycle. From product design and development to regulatory compliance, testing and validation, packaging and sterilization, and logistics and supply chain management, we are committed to providing a complete range of services and solutions that enable our customers to deliver the best possible outcomes for patients.

Product design & development

Product design and development is a key service that Croom Medical provides to its OEM customers. Our experienced team of engineers and designers can work closely with our customers to develop new and innovative orthopedic implant solutions tailored to their specific needs. We utilise advanced design tools and technologies to ensure that our products are optimised for performance, functionality, and manufacturability. Our design and development process is rigorous and efficient, allowing us to quickly bring new products to market while maintaining the highest standards of quality and safety.

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Testing & validation

Croom Medical offers a range of testing and validation services to ensure the safety and efficacy of our orthopedic implant solutions. Our comprehensive services include mechanical testing, materials analysis, and performance testing, as well as 510(k) submission support for additive manufacturing. We utilise installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for new equipment and processes, along with Design Failure Mode and Effects Analysis (DFMEA) to identify potential failures and mitigate risk. Our team of quality professionals can also support full process transfers, ensuring seamless integration of our customers’ processes while maintaining the highest levels of quality and compliance.

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Regulatory compliance

At Croom Medical, we are committed to upholding the highest levels of regulatory compliance for our orthopedic implant solutions. Our team of quality professionals ensures compliance with all applicable regulations, including ISO 13485 and FDA regulations. We also offer regulatory support for 510(k) submissions, including technical writing and submission strategy development. Our quality management system is built on the principles of continuous improvement, with regular internal and external audits to maintain compliance and ensure the highest levels of quality.

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Logistics & supply chain management

At Croom Medical, we understand the importance of timely and efficient delivery of our orthopedic implant solutions to our OEM customers. Our logistics and supply chain management capabilities include just-in-time delivery, inventory management, and international shipping. We work closely with our customers to develop custom supply chain solutions that meet their specific needs and requirements. With our advanced tracking and traceability systems, we ensure complete visibility of our products throughout the supply chain. Our team of logistics and supply chain professionals are committed to providing the highest levels of customer service, ensuring that our customers receive their orthopedic implant solutions on time and in full.

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Tooling & fixtures

With four decades of experience in precision manufacturing, Croom Medical has developed extensive capabilities in tooling and fixture manufacturing. Our origins as Croom Precision Tooling gives us a deep understanding of the critical role of fixtures and tooling in the manufacturing process. We have invested in state-of-the-art CNC machining technologies, including 5-axis machining, to produce complex and high-precision fixtures and tooling. Our experienced team can design, manufacture and validate fixtures and tooling for our OEM customers, ensuring that each component meets the highest standards of quality and reliability.

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