Our client
For over a century, our client has been a global leader in health technology, dedicated to making a real impact on people’s lives through innovative solutions. Their mission is to positively influence billions of lives annually, including those in underserved communities. With a diverse team spread across many countries, their commitment to innovation and quality has firmly established them as a trusted brand in healthcare.
Challenges faced
In the highly regulated market of medical device development, our client faced a significant challenge when the Food and Drug Administration (FDA) identified areas of concern during an inspection. This highlighted the urgent need for an improved risk management strategy in their precision diagnostic imaging products’ correction and removal processes. Ensuring the reliability, proper functionality, and safety of these products for both patients and operators, while also considering environmental impacts, became crucial.
Adding to the complexity, our client had to adhere to ISO 14971:2019 and ISO/TR 24971:2020 standards. These international benchmarks set the gold standards for best practices in the medical device industry, covering everything from initial design to distribution and ongoing maintenance. Meeting these requirements is not just about regulatory compliance – it is about committing to the highest levels of safety and quality throughout the entire product life cycle.
Paving the way to success
Our specialized team conducted a thorough retrospective examination, covering Health Hazard Evaluations (HHEs) and related reports. This in-depth analysis involved reviewing defect records, complaint information, design changes, Corrective and Preventive Actions (CAPAs), Supplier Corrective Action Requests (SCARs), and other relevant data. By implementing two robust quality protocols, our team meticulously reevaluated more than 35 product-related issues.
Using a seamless blend of qualitative and quantitative methods, we identified risks such as hazardous situations, the sequence of events, populations at risk, severity levels, and occurrence rates. This comprehensive approach refined the risk assessment process to align closely with the guidelines of ISO 14971:2019 and ISO/TR 24971:2020, resulting in a higher level of precision and compliance.
Benefits unlocked
Our tailored efforts delivered a wide range of benefits, notably ensuring uninterrupted operations for our client’s diagnostic imaging business.
Our refined risk assessment approach significantly optimized the corrections and removals process, streamlining interactions within the Quality Management System (QMS) and boosting overall efficiency and responsiveness. This improvement enabled the swift execution of critical actions such as Corrective and Preventive Actions (CAPAs) and recalls, establishing a more agile and responsive system.
This enhanced operational agility positively influenced various facets of our client’s operations. By delivering measurable results and showcasing specific improvements, we met our primary objective and significantly boosted the efficiency and resilience of the entire operational framework.
Exceeding FDA expectations and completing the project ahead of schedule underscores our team’s commitment and diligence. Discover more about our expertise and dedication to excellence in our Life Sciences Solutions. If you’re passionate about driving transformative projects, explore our career opportunities in healthcare consulting. Together, let’s shape a future that’s safer for all!
