Simulation

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 […]

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

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

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

Developing a medical device is no walk in the park. It’s more like a hike through regulatory mountains, clinical valleys, and a few budget cliffs. The path from concept to FDA clearance is notoriously complex. However, computational modeling is the relief, the beacon of hope that innovative companies are using to navigate this complexity, reaching

Simulation has always been an engineer’s best friend. Now, it’s becoming a regulatory ally, too. From the FDA to the EMA, agencies are increasingly open to in silico evidence to support design validation, safety assessment, and performance claims for medical devices. If you’re using COMSOL Multiphysics, you’re sitting on a mountain of valuable, submission-ready data,

Sterility is everything in the OR, and orthopedic implants are no exception. Whether it’s a hip prosthesis, spinal rod, or knee replacement, even a microscopic contaminant can lead to infection, inflammation, or rejection. Enter laser ablation: a precise, residue-free sterilization technique gaining traction for orthopedic components. And COMSOL, a leading simulation software, is playing a

Pacemakers have long been a marvel of medical engineering, but for decades, they had one fatal flaw: MRI machines. Strong magnetic fields and radiofrequency (RF) energy can heat leads, distort images, or cause dangerous malfunctions. That’s no longer acceptable. Today, engineers must design pacemakers to be MRI-safe, and simulation is their most powerful tool. The