The international standard ISO 14971:2019 serves as the foundation of risk management in medical device development. At AltaSim Technologies, we’ve found that using simulation tools leads to your medical devices adhering to the ISO 14971 standard more quickly, while also maintaining and even improving your precision and accuracy. ISO 14971 The ISO 14971 standard has […]
Risk Management with Modeling Tools Under ISO 14971 Read More »
No matter how sleek the design or advanced the technology, medical devices don’t live in a bubble. They’re dropped, frozen, overused, submerged, sterilized, jostled, flexed, and sometimes asked to operate inside bodies that are, well, different than a textbook diagram. This is why testing medical devices under extreme conditions isn’t optional; it’s essential. And rather
Built to Withstand: Using Simulation to Model Device Behavior Under Extreme Conditions Read More »
Imagine you’re designing a cutting-edge medical device that might save many lives. You’ve got a brilliant concept, a solid engineering team, and a looming deadline. Now the million-dollar question: Should you test it in a lab or run it through a simulation? Enter the age-old tango between in vitro (physical lab testing) and in silico
In Silico vs. In Vitro: When to Simulate and When to Lab Test Read More »
Ask a medical device engineer if their product is FDA “approved,” and you might see them twitch. That’s because, in FDA-land, ‘approved’ and ‘cleared’ aren’t synonymous. They’re different regulatory universes. Mix them up in a submission or investor meeting, and you’re not just in for some awkward course corrections, but also potential delays and misunderstandings
Cleared vs. Approved: What Does the FDA Mean? Read More »