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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...

The Brexit from the EU may be causing a few medical device manufacturers some anxiety over the future of their CE Certificates from British Notified Bodies (e.g., BSI and SGS). The following article discusses this issue briefly:http://www.raps.org/Re...

I was having a chat with a friend who was telling me how tech startups are coming up with technologies aimed to replace accountants. While this shift towards automation may not be something new, obviously we have start seeing McDonalds among many oth...

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...

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...

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...