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Edwin Lindsay, Compliance Solutions Life Sciences - Guiding Smart Regulatory Decisions | LSI USA '24

Compliance Solutions offers straightforward, practical and effective advice to guide companies through the maze of quality, regulatory affairs and approval processes
Speakers
Edwin Lindsay
Edwin Lindsay
, Compliance Solutions Life Sciences

Edwin Lindsay  0:00  
Good morning, everybody. Compliance Solutions is a consultancy company with COVID quality regulatory and clinical. We're based in sunrise in Miami, but also in Glasgow and Dublin. We cover all medical devices and IVDs. And we try to make it a one stop shop for small SMEs, startups spinouts. My passion is innovation. I've been in consultants again for 20 years. But before that, I've worked with a number of startups. So I've been on both sides of the fence with regards to how to pick product to market, I'll also get more into medical device company, which we single use retractor. So I've got kind of foot in both camps. What we've tried to do is build a team with areas of expertise that helps companies so they don't have to go out and get other consultants or contractors to recover from from class one to class three medical devices. In vitro diagnostics, they companion diagnostics, and we've recovered everything from just general quality, regulatory, and clinical. So we can give the small companies a package, and we can allow, we can easily manage it. So you're not having to go out and get more other consultants, you know what, yeah, especially with startups, you know, that those are, what the cost is, rather than just having to bring in two or three different people. And say, We're based in UK, Dublin, and then also just recently established the US and sunrise, we've got a number of clients that we've linked to the UK, the US with 510, KS, we've been working with a number of us clients, over the over the years, back then as our authorized representative in Europe, but then actually coming into the US and starting to work with them a bit more. We're thinking most of these companies were thinking along to 510 K with new innovative products. They say the bulk of my colleagues are startups spinouts. And we understand what is needed by some who understand that you need to make decisions, we will make the decision about you rather than just throw things at you. So we are very hands on, we will walk through the process with you. We will train the staff to make sure that they can then continue that on. And that's just been my ethos because I've sat on the other side when we've needed support by consultancies and I've saw what it was like when you struggled when you were just giving documents and you didn't understand you needed help. And the help was just here for that's what you need to do. But we make consultants are all trained to understand what the clients need and actually help them deliver it rather than just hope it does get there because the passion is I like to see these products be delivered. I want to see them on the marketplace. Thank you

 

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