Question
We're a small medical device (IVD) manufacturer and we're trying to find a suitable PLM system to help us manage our device design and manufacturing.We've already looked at Arena Solutions, Propel, Oracle Agile, and Upchain plus several others that d...
Can you explain what Article 22: System and procedure packs of EU MDR means?What, exactly, do we do to comply with this article?
Hi Everyone, We're new to the FDA medical device, and we're looking to implement an eQMS system into our workflow. We've looked at Greenlight Guru, MasterControl, and Enzyme. Was hoping to get some feedback from the folks here regarding the pros/cons...
I'm based in India and would like to understand the overall regulatory workflow for medical device product development. What are the documents I need to create for entry into the US market? I've started on our 510(k). Do I need to have GTIN and GUDID...
Hello,How would you classify fibrin-glue like medical device? The intended purpose of the device is management of bleeding in traumas or surgical procedures (i.e endoscopy) IIb or III and why?
A subscriber (Irina) asks, "The TSE Risk estimation document (Germany, 1994), "Safety Requirements for Medical Products Derived from Body Constituents of Cattle, Sheep, or Goats to Avoid Risk of Transmission of BSE or Scrapie," requires an estimate o...
The DIS (Draft International Standard) of the review of ISO 14971 - Health Product Risk Management - should be circulated to national committees soon. The ballot will remain open until mid-October.It is extremely important for those involved to revie...
I am looking for a cloud-based Quality management system with at minimum Document change management and Design control features. Any recommendations? source: https://www.linkedin.com/groups/78665/78665-6422825542688477185
One of the themes I come across regularly with my medical product manufacturing clients is uneven skills in investigation and determining root cause through a rigorous and adequate Root Cause Analysis (RCA). In some cases, it is newer team members wh...
If you do business in Europe, I heartily suggest you familiarize yourself – and quickly – with the changes in MDR 2017/745 and MDR 2017/746. See http://bit.ly/EU-MDR-Labelling-Compliance The EU Medical Device Regulation (MDR 2017/745 & MDR 2017/746) ...
