Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a ...

In January 1990, FDA published Device Recalls: A Study of Quality Problems (55 FR 21108, May 22, 1990). The study reported that 44% of quality problems were attributed to errors or deficiencies that ...

A monthly overview of things you need to know as an architect or aspiring architect. Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with ...

Have you ever thought about how and why something was designed? Who was considered a “stakeholder” for the design? And what biases are baked within the process of designing something? These are some ...

It's worth even more in the hands of a designer ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

Tell us about the control strategy you've implemented with AstraZeneca and its external partners. Over the last year, we worked to improve our control strategy for drug delivery devices. Our goal was ...

“How do we select the right design partner?” “Where can I find evidence that design really works?” “Can design have any impact beyond products?” These are real questions that we’ve been asked by our ...

This chapter discusses the structural design context for materials selection, the materials selection process, the evolution of computer systems that support the design process, and the needs for ...

It is now practical to write software for real-time systems long before the actual computer hardware is sitting in a physical prototype. In today’s world it is rare to find electromechanical devices ...