Challenges
The manufacturer sought to leverage 3D printing technology to produce medical devices at scale, with a mission to improve access to care in remote and conflict-affected regions in Canada and internationally.
While manufacturing was centralized, the use of additive manufacturing introduced regulatory challenges, including:
– Demonstrating process consistency and repeatability for 3D printed devices
– Validating printers, materials, and software as part of the manufacturing process
– Managing design changes inherent to digital manufacturing
– Aligning regulatory expectations for an emerging manufacturing technology across global markets
As a Canadian medical device manufacturer, the client required a regulatory strategy that supported innovation.
Solutions
We developed a risk-based regulatory and quality strategy tailored to additive manufacturing, including:
– Clear regulatory positioning under Canadian medical device regulations
– A robust quality management system addressing risk, production controls and process validation
– Regulatory documentation designed for reuse in support of a fast-growing portfolio of devices
– A post-market surveillance and feedback framework to monitor real-world performance and inform
continuous improvement
This approach ensured regulatory confidence while preserving the flexibility and speed of 3D printed manufacturing.
Results
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Successful establishment of a compliant 3D printing manufacturing framework in Canada
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A scalable regulatory foundation supporting future global market expansion