Recent Articles
The international standard ISO 14971:2019 serves as the foundation of risk management in medical device development. At AltaSim Technologies, we’ve […]
No matter how sleek the design or advanced the technology, medical devices don’t live in a bubble. They’re dropped, frozen, […]
Imagine you’re designing a cutting-edge medical device that might save many lives. You’ve got a brilliant concept, a solid engineering […]
Ask a medical device engineer if their product is FDA “approved,” and you might see them twitch. That’s because, in […]
Developing a medical device is no walk in the park. It’s more like a hike through regulatory mountains, clinical valleys, […]
Simulation has always been an engineer’s best friend. Now, it’s becoming a regulatory ally, too. From the FDA to the […]
Over the past two decades, I have attended the COMSOL Conference, presented technical sessions, taught workshops, and participated in panel […]
Every year, hundreds of thousands of people in the U.S. undergo life-changing knee replacement surgeries. These procedures, while meant to […]
Sterility is everything in the OR, and orthopedic implants are no exception. Whether it’s a hip prosthesis, spinal rod, or […]
Pacemakers have long been a marvel of medical engineering, but for decades, they had one fatal flaw: MRI machines. Strong […]