Quality control

At Croom Medical, we are committed to excellence in quality and compliant with FDA, ISO 14001 and ISO 13485.

We have a team of experienced quality professionals who oversee every aspect of our manufacturing processes, from incoming materials to finished products. Our quality control processes include material analysis, dimensional inspection, surface roughness testing, mechanical property testing, and functional testing. We also utilize statistical process control (SPC) to ensure consistent quality and identify areas for continuous improvement. Our commitment to quality control has earned us multiple certifications, including ISO 13485 and ISO 14001, and our customers can trust that every orthopedic implant we produce meets the highest standards of safety and reliability.

Inspection & testing

At Croom Medical, we understand the critical importance of rigorous inspection and testing in ensuring the safety and efficacy of our orthopedic implant solutions. Our inspection and testing services include dimensional inspections, visual inspections, and materials analysis using a range of advanced techniques and equipment such as CMM, X-ray, and SEM.Our mechanical testing services include tensile, compression, and fatigue testing to ensure the strength and durability of our orthopedic implant solutions. We utilise advanced equipment and software to perform testing in accordance with industry standards, such as ASTM and ISO.

Quality management system (QMS)

Our Quality Management System (QMS) is designed to comply with all relevant regulatory requirements, including ISO 13485 and FDA regulations. We have implemented a robust quality system that covers all aspects of our operations, from design and development to production, testing, and distribution. Our QMS ensures that we maintain the highest levels of quality and compliance in all our processes and operations.

Process validation

We employ a comprehensive approach to process validation to ensure that our processes are consistent and repeatable, and that the finished products meet the highest standards of safety and efficacy. Our process validation includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for new equipment and processes. We also utilize Design Failure Mode and Effects Analysis (DFMEA) to identify potential failures and mitigate risk throughout the product development process.

Continuous improvement

At Croom Medical, we prioritize continuous improvement in all aspects of our operations, including manufacturing processes, product development, and quality control. We utilize various methodologies, such as Lean Six Sigma, to identify and eliminate inefficiencies, reduce waste, and improve quality. Our team of experienced engineers and quality professionals are constantly seeking ways to optimize our processes and drive innovation. Through ongoing training and development, we empower our employees to make data-driven decisions and implement improvements that enhance our capabilities and deliver exceptional value to our OEM customers.