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My son was just arrested for using this in his hacking club at high school. Be careful if you have kids with one. According to witnesses in the room, he was showing it to kids in h…

I recommend you all read the 2023 FDA cybersecurity expectations before commenting. https://www.fda.gov/media/119933/download

For those of you in FDA regulated devices, my clients started receiving FDA NSE letters for not performing fuzz testing. For example, "Though you have provided penetration testing,…

Man this applies to me. I got an bioengineering degree and had to go to the US to find work. I started at $30K in the US and now I'm up to over $350K/yr. Would love to come back to…

I'm a regulatory consultant and I am currently submitting at least 5-10 510ks/DeNovos per week to FDA for AI/ML devices for a variety of companies. I can't imagine the actual throu…

I'm currently working on a required CDC (Center for Disease Control) reporting function for a COVID test. For a second I thought this article was going to be extremely helpful.

I audit a lot of these Fentanyl API (Active Pharma Ingredient) factories in China. Its noticeable to me when I go through the warehouses as to how much product is going to Mexico. …

I think those are generally good questions but the majority of submissions that FDA CDRH are reviewing are for imaging of ultrasound, MRI, XRAY etc, with a sprinkling of audio AI a…

That FDA review division does require that information and testing to be supplied with infusion pump testing. In fact, they are one of the few that routinely asks for substantial t…

The new draft literally doesn't change anything. It just defines some of the things that FDA has been already asking for in the past 7 years for every device submission. Just my op…

Remember the square bonzai kitten thing. https://www.wired.com/2001/02/fbi-goes-after-bonsaikitten-co...

I couldn't disagree with you more. I live in BC (and ONT), and all of us that migrated from the UK are much more pro-monarchy than most brits back in the homeland.

Thanks for making me laugh. Very witty...

I review software for at least 3-5 companies per week as part of FDA submission packages. The FDA requirements require traceability between reqs and the validation. While many smal…

Before I entered management, I spent about 15 years as an engineer building "greenfield" drug manufacturing sites using automation packages such as Allen-Bradley, Emerson DeltaV an…