Medical device Design Reviews are critical to the success of product development. So much so that the infamous Design Controls waterfall diagram shows a design review after every major design control ...

Designers and engineers have often looked to the environment and how Mother Nature has accomplished phenomenal design solutions for inspiration over the ages. Perhaps all that is new about this ...

Successful new medical devices hinge on the designer’s understanding of the specific requirements of the procedures they support, including factors like usage frequency and duration. This is ...

These definitions as written out by AAMI (The Association for the Advancement of Medical Instrumentation) offer clarity, helping designers recognize and address these risks effectively in product ...

It’s been over 15 years, but the advent of Apple’s iPhone still represents one of the biggest paradigm shifts in the world of consumer technology. It fused style with substance; form with ...

When it comes to medical device design—a broad category that includes a range of different machines performing countless critical functions—the stakes are high. Because no matter the application, ...

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

Secure by design didn’t just pop up in the medical device industry with the update to the Food & Drug Administration (FDA) guidance on cybersecurity recommendations. However, its inclusion in this ...

Victoria-based company now has offices in Irvine, CA and Toronto, ON Many integrations fail, and I'm proud to say that ...