The Year 2018 is over so let´s see what is ahead of the medical device industry in 2019. (Podcast episode page: https://podcast.easymedicaldevice.com/5/)

I will provide the audience with 2 axes of topics:

• Technology trends

Some would say that these have nothing to do together but I disagree. As Medical Device Regulators, we need to understand technology to be accurate in our choices.

Is there any risk for the patient? What are the parameters you need to verify in a Technical File? You cannot do that without knowing what are the different technologies.

I will list you some technologies that you need to follow or to understand at least. As you may assume a lot of them will be digital or software based. So don´t think that this is the future because, in reality, it´s already here.

Regarding regulations, as there are new technologies, this should also change. We need to identify what is not accurate anymore on our regulations to cover these new technologies.

Recently, 2 documentaries were released “The bleeding edge” and “The implant files”. They focus on the fact that some regulations are not good enough. No regulation is really perfect it´s why some updates are needed. And I think the regulators understood that because a lot of countries are updating their laws. Europe with MDR and IVDR. The USA is now in the process to modernize the 510(k) process. MDSAP is helping to harmonize the regulations worldwide…

So many things are ongoing. Let me know if I forgot something. Write a comment below.

• iWatch from apple FDA approval: https://bit.ly/2FawowO

https://www.youtube.com/embed/ei-4gToN8Ek?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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