What you need to know regarding quality of patient-specific implants


Martinez-Marquez D. had developed a workflow of ”18 Quality Control Gates” for additively manufactured patient specific implants

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

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About us

We are Ortho Baltic, in market more known as producer of custom-made prosthetic-orthotic devices under the name of Ortho Baltic, in 2012 we have invested in additive manufacturing technologies and expanded our made-to-order services to the design and production of patient-specific joint endoprosthesis, cranial and maxillofacial implants, bone plating systems, dental & jaw restoration implants and patient-specific surgical guides as well.

Taikos Ave. 131A
LT-51124 Kaunas, Lithuania

Tel. 8 37 473970, Fax 8 37 473863

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