FDA regulation
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How to do Post-Marketing Surveillance in the US (vs EU)?
Post marketing Surveillance for medical devices in the US market is done differently than in EU. So learn on this podcast how to be prepared with Rob Packard. We will talk about multiple sort of devices and how FDA is handling the way to do Post Marketing Surveillance so if you are selling to the US market, check this.
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Regulatory Pathway: How to reach the US market? [510k exempt]
If you are willing to reach out to the US there may be multiple strategies. We will talk today about MysteryVibe that started to evaluate the market and identified that their product is class IIa in EU and Class II in the US. But in the US this is 510k exempt so let's here their journey.
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Why do you need an Initial Importer for the US Market?
This is not anymore a question, you need an Importer for the US market. But what are the rules and who can do this. Stéphen Toupin from Dawa Medical will help us understand why your products are blocked at the US Customs.
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When you think “510k” but FDA says “DeNovo” with Spencer Jones
What would you think if you planned all your regulatory strategy for FDA 510k and when you submit, the FDA says to you that this should go DeNovo. Spencer Jones will tell us what he learned during this process.
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How to sell Medical Devices online in the EU and US?
If you are selling medical devices online or if you plan to sell some, then this episode is for you. This will help you to understand the struggle that you may have or will encounter. Michael Wetherington and I will provide you the keys to be successful in that field.
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FDA: Is the Emergency Use Authorization worth it? (EUA)
This process called EUA was really famous last year when everyone wanted to register its face mask or respirator or covid-19 test in the USA. After 1 year let's see the conclusion of Michelle Lott on it.
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How to get some help from Medical Device Regulators with Cliff Bleustein
In this case study we will see how Apos Therapy was able to register his product in the US for certain therapy. Cliff Bleustein; President and CEO of Apos Therapy is my guest today and you'll see that for a CEO he knows a lot about regulatory affairs.
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How to register your Medical Device through 510k with Michelle Lott
Michelle Lott is my guest and will help us understand the 510k registration process with the US FDA. Should you use it? Is this changing? Learn everything in 1 episode.
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5 FDA Myths for Start-Ups with Justin Bushko
Justin Bushko from Concise Engineering will share with us 5 FDA Myths that exist on the Start-up world. Medical Devices Start-Ups should satisfy Investors and Regulatory, and this can create some strange assumptions. Let'S listen to that.
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Register your Medical Device in the US with Michelle Lott (FDA)
There are many ways to register a Medical Device in the USA and I propose you to listen to Michelle Lott that will tell you the basics of the FDA regulations.
