Currently, the variety of additive manufacturing technologies and biocompatible materials applied for 3D printing of medical devices is expanding. All of the virtues that this rapid growth brings to the medical device industry and the patients suffering from complex pathologies, are already re shaping current medical device regulation. Nevertheless, factors such as high variability of devices design and changeable customer needs necessitate the urgent formulation of comprehensive additive manufacturing quality control procedures. Medical regulatory bodies are confronted with updating standards to enable innovation, while also ensuring long-term patient safety and product performance. Therefore, it is essential to increase current focus on product quality by encouraging companies to adopt best practices.

Martinez-Marquez D. et al. (2019) in collaboration with a few patient-specific device-oriented companies, including Ortho Baltic, had developed a workflow of ”18 Quality Control Gates” for additively manufactured patient specific implants. We believe it is important topic for whole industry, therefore we invite you to read the article here: https://www.ncbi.nlm.nih.gov/pubmed/31554254