In the latest episode of Project Medtech podcast RAM Technologies president Greg Tuers shared some insights on the 60601-1 standard and tips on manufacturing medical devices in an interview with Duane Mancini, the host of the Project Medtech podcast series.
In this episode Greg Tuers touched on what it means that 60601-1 is “harmonized” standard globally, and what Intended Use versus Normal Use and MOPP versus MOOP mean and why they are important in medical device design. He also offered tips when moving from the medical device prototype to designed-for-manufacturing version. For example, if you choose off-the-shelf components, be sure to source long-life parts.
“If you look at a commercial motherboard that’s on the market, it’s on the market for 12, 18 months. I’m sure you want your product to sell for at least 8 years. You do not want to go back to the FDA for another 510(k), because the motherboard is a critical component.”
On the subject of medical power supplies, Tuers explained that customers normally come to RAM Technologies, “at the beginning of their design phase or maybe after they’ve done the prototype and now they’re starting to look at ‘How do we certify it to 60601?’” Certified medical power supplies can pass the rigorous safety standards that standard commercial-grade power supplies might not.
For more free tips from Greg Tuers, don’t miss Project Medtech Episode 106: “Does Your Device need to Comply with IEC 60601?” The podcast is also available on Spotify, Apple Podcasts, and Google Podcasts.