Software verification and validation
Health Canada’s 3D Printed Implantable Devices.
According to Health Canada, “This guidance document is intended to aid manufacturers and regulatory representatives in preparing medical device license applications for 3D printed medical devices. As with all Class III and IV medical devices, devices produced by additive manufacturing or 3D printing, are subject to the Medical Devices Regulations (Regulations) and require a review of submitted evidence of safety and effectiveness before a license can be issued”.
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