Question
First, I have to say how liberating it is to be writing you on my own site versus LinkedIn. I literally feel a wave of relief washing over me. First, I don't have to count characters. Second, I've already used italics(!), something LinkedIn doesn't ...
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...
I'm curious to hear what other industry professionals feel about the Netflix documentary "The Bleeding Edge" that recently debuted offering a scathing exposé of our industry. My thoughts: For sure there are companies that have not always held patient...
Malene Grouleff
PR Strategist: Robotics, Automation, Innovation. Strong media relations skills. Social Media.
August 2018
From the looks of things, pretty big. If you tuned into the first of FDA’s Case for Quality webinars, you learned about FDA’s shift their from 'compliance with regulations' to 'device quality.' Get the replay and register for part two at https://medg...
Yesterday I sent a group announcement to the Medical Devices Group (pop. 354,158) entitled, "
As shared with the Medical Devices Group today, July 17, 2018. LinkedIn will destroy this group once and for all. IF YOU VALUE THIS GROUP, even a little, you need to act today and join my mailing list. Please visit this address now: https://medgroup...
LinkedIn will destroy this group once and for all. IF YOU VALUE THIS GROUP, even a little, you need to act today and join my mailing list. Please visit this address now: https://medgroup.biz/MDG-SITE. IT MAY BE THE ONLY WAY I CAN TALK WITH YOU IN THE...
Mohamed Zitouni
Principal | Senior Procurement and Supply Chain Consultant | Chain Bridge Services
July 2018
Hello members, I am a Procurement and Supply Chain consultant for a Medical Device startup which is building a prototype. I have a question about a process. Would you consider the prototype stage a part of the FAI process or will you conduct this sep...
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...
