The MDR at the point of care is simpler than most of what you will read about it. This guide covers the minimum you need to do to be compliant, and explains why doing more is not the same as doing better. In short Why this guide exists A lot has been written about the …
Tag: pointofcare
Is ISO 13485 actually necessary for hospital 3D labs?
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 …
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.