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If you've ever known someone who has Parkinson's and have watched their physical health decline faster than their mental acuity, then you know the torturous life they lead. Parkinson's has no cure and medication alone isn't enough but DBS has been sh...

There is a lot of ado about the approaching changes in the medical device directive, however most of the regulatory professionals do not even know the content of the draft proposals. Here you can download the draft proposals and get credible informat...

Around the middle of May, I attended TGA’s workshop on Post-marketing requirements for Medical Devices. At this event, TGA reinforced their more stringent dossier criteria for medical devices. This impacts on all classes of medical devices, particula...

I'm trying to understand which countries' regulatory bodies have country of origin requirements and what does "country of origin" actually mean for these countries. Which countries have "country of origin" approval requirement for medical devices?If ...

I was the first graduate from UT Austin EE department with a biomedical degree many years ago. Worked in EE labs, Marconi and TI during my undergraduate school years, then I went to biomedical graduate school in Houston for a PhD that I did not compl...

Are you or your 3PL maximizing the cube in your shipping container? What if you could double stack odd size, fragile, or high value units on frames and ship damage free? Is that cost savings important to the medical device community?