Many hospital 3D labs I speak with run into the same situation. They start looking into the Medical Device Regulation (MDR) and quickly hear the same advice: “You need an ISO 13485 Quality Management System.” ISO 13485 is indeed a well-established standard for medical device manufacturers. But for hospital-based 3D labs producing custom-made devices, the …
Tag: pointofcare
3D printing at Point-of-Care
3D technology has found it’s way to the hospital and is significantly improving patient care. In the article below I highlight the opportunities and identify the risks of 3D printing in a hospital setting. It talks about regulatory and quality management aspects and links to helpful guidance documents.