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Am I recommending cheating or doing something illegal? No. But my friend Rick wrote me about how Medicare's competitive bidding program is killing his business. I did a little digging and found this article in Forbes: http://medgroup.biz/bidding-fias...
Don’t ever believe what you hear. Instead, look it up. I think the software requirements are minimal in the newly released ISO 13485:2016 standard, but other experts disagree. In the QSR, software is also covered, and regulatory requirements are incl...
Do you belong to a medical device association? Has membership ever helped your business?If so, which one? (I have a list below, with links.)What do you look for in membership? A vague hope someone can introduce you to a decision maker? A peer network...
Recently I received an email inquiry from a LinkedIn group member that asked about the appropriate inspection requirements and operator certification for soldering electronic components to a printed circuit board for medical devices.The ISO 13485 Sta...
Whew. You got through the unique device identification (UDI) submission process. But you're not done yet. In http://medgroup.biz/UDI-next-steps, John Lorenc from Reed Tech explains UDI doesn’t end with your submission to the FDA’s GUDID database. "Af...
What will the regulators do in response to the 2016 changes?How do we revise our supplier controls?When will the standard be harmonized with the EU directives?In one of my previous announcements a couple of people responded to my announcement indicat...
At MDMS a few weeks ago, Mike Sperduti led a spirited talk with medical device CEOs, VPs, and Directors of Marketing about effective inside sales strategies to drive organic growth. The discussion was so compelling, I asked Mike to bring it to the en...
Does anyone know if there is a standard to detect counterfeit parts from entering your supply chain when purchasing from an Independent Distributor due to obsolescence?source: https://www.linkedin.com/groups/2070960/2070960-6115363616561651715
As originally asked by Carl Mayer I wonder aloud if the industry's words are matched by our actions. I read a lot about how big data is going to change our businesses and improve patient outcomes, but I'm not seeing much of it in practice so far. For...
Gavin Bogle, an intellectual property lawyer I met at PEDS2040 surprised me when he said, "At this point, diagnostics are really not patentable." I recorded his 5-minute answer at http://medgroup.biz/not-patentable Gavin: Under “The Mayo Clinic v. Pr...
