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In this post, we recap a recent webinar hosted by Jama Software on the topic of requirements management in the medical device industry Requirements management solutions enable the unification of siloed processes and data that often reside in outdated, disparate, and disconnected legacy systems. However ineffective and inefficient, the industry still relies overwhelmingly on static […]
Design Controls have been an FDA Quality System Regulation since 1997. Having worked on developing products in the regulated medical device industry for over 35 years, I have compiled a list of the five key takeaways for implementing design controls and achieving success in commercializing medical devices: Design Controls not only help achieve regulatory compliance, […]
Requirements management (RM) is a challenge for many companies, partly due to the ambiguity involved in software development. First, you must understand the client’s requirements. Second, you must match those requirements to critical processes. RM is a component of requirements engineering (RE), which bridges the divide between a client’s needs and what developers create. When […]
This post on Software as a Medical Device (SaMD) development is written by Mercedes Massana, the Principal Consultant of MDM Engineering Consultants. SaMD software is software intended to be used for one or more medical purposes that do not require embedding in a medical device. These purposes can range anywhere from helping to diagnose or […]
If you’ve heard the terms “verification” and “validation” used interchangeably, you aren’t alone. However, this creates confusion during the testing process, and if you’re building products in highly regulated industries, it’s critical that products perform as expected and expensive errors are avoided. Unclear and incomplete requirements can be frustrating for software developers, and if developers […]