In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re drawing inspiration from an item I wrote about recently in one of my MPO editor’s letters. Specifically, I’m referring to the news of an assisted suicide machine that was being considered for introduction in Switzerland, where assisted suicide is legal under certain conditions. However, following the first instance of someone successfully using the device within the country, several people involved were arrested and the situation is being investigated further. Specifically, the following questions are addressed:

• Should this be a device that goes through a regulatory review? Given its purpose, should it be treated as a regulated device?
• If it were a regulated medical device, what would its classification be?
• What would be its pathway to market?
• Does risk have the same definition for a device like this?
• Similarly, what about safety and efficacy? Is testing or a clinical trial required or even appropriate?
• Is there a precedent for this type of product? Not talking about a predicate here but a precedent.
• Any final thoughts on what’s important for this discussion/topic?

Listen to this discussion and see if you have a better understanding of CAPAs. If you’d like to share thoughts, ask questions, or have a suggestion

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