Mandatory QMS for all Classes of Medical Devices per EU MDR
Quality management system (QMS) is a structured framework that ensures an organization consistently delivers products meeting customer and regulatory requirements. Notably, EU Medical Device Regulation (MDR) has specified mandatory QMS for all classes of medical...
10-Step Guide to Hassle-free Integration of UDI into QMS
Integrating unique device identification (UDI) into your quality management system (QMS) will enhance traceability, compliance, and operational excellence. UDI will improve efficiency of the medical device supply chain as well as enhance patient safety and post-market...
How to Deal with Medical Device Industry Quality Challenges?
In this blog, we have discussed common medical device industry quality challenges. Additionally, we have provided some tips on how to overcome them. What are medical device industry quality challenges? Medical device industry quality challenges are technical,...