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During the next three years I guarantee that every single medical device manufacturer will eventually become sick and tired of hearing the phrase “risk-based approach.” I’ve been there for about 5 years, but there are a few new updates to the standar...
Director, Quality and Compliance at Resolution Bioscience
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...
Principal Consultant at Gish Consulting
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...
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
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One of my clients sent me an email this morning asking, which upcoming regulatory changes will affect the Declaration of Conformity (DoC) for CE Marking of medical devices. They also requested a link to the new EU legislations which will come into fo...
Regulatory Affairs - MEDKONSULT medical technology
Hi, I have some doubts about conformity assessment of IIa MD. We apply Annex II with exclusion of section 4. When we launch a new MD or when we make any substantial change, we always undergo an approval process with our NB.Recently, I have come acros...
A single-member LLC with a non-US alien owner wants to sell Class I, 510(k)-exempt medical device via Amazon FBA. The manufacturer of the device is a foreign business entity and has a valid FDA registration. The LLC wants to sell the medical device a...
Simply a gift for you today. If you have anything to do with medical device quality systems, click here for FDA slides for immediate download. Four slides that stood out to me It was hard to narrow down the four hours from four presentations to four ...
How do you see this changing going forward?Study: Initially CE Marked medical devices have higher recall rateU.S. medical devices which won CE Mark approval in the European Union prior to gaining FDA clearance have a nearly 3 times higher rate of saf...
Project Manager -Regulatory Affairs en Arazy Group Consultant
Hello all,Maybe this is a basic question for many of you, but I have a doubt regarding the Standards that should be declared on the Declaration of Conformity according with the MDD 93/42/EEC.The Situation is, the harmonized standard EN 60601-1:2006/A...