The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
In this article Bryce Telford and Logan Luke discuss the unique considerations, such as sterilization and packaging, to chart a course for regulatory approval of 3D-printed devices. Read the Article in ODT Learn more about the authors.
Most medical products require some level of microbiological control. For many products that means production in a controlled environment. EN 17141:2020 was recently published to give manufacturers guidance on controlled environments and biocontamination control. EN 17141:2020 supersedes the older ISO...
