Blog on SW development and lean principles
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Potential Impacts of Quality Management Systems on Software Development Productivity
As a software developer, you’re probably familiar with quality management systems (QMS) and their role in ensuring the safety and effectiveness of the end product. But have you ever thought about how QMS could potentially impact your productivity as a developer, in positive or negative way? Possible negative impacts of a QMS Here are a…
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Most Common Challenges in Medical Device Software Development
Working in the medical device industry, you know that the development process can be complex and challenging. Here we’ll explore some of the most common challenges in medical device software development and how they impact the daily work of developers. 1.Regulatory requirements One of the biggest challenges in medical device software development is meeting regulatory…
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Why Quality Management Systems and Regulations Matter in Medical Device Software Development
Working in the medical device industry, it’s important to understand the role that quality management systems (QMS) and regulations play in ensuring the safety and effectiveness of the end product. Role of Quality Management Systems (QMS) QMS is a framework of policies, procedures, and processes that a company follows to ensure that their products and…
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Understanding Software Medical Device Regulation in the US and EU
You may not have initially considered that your software product could fall under the umbrella of medical device regulation. However, it’s important to understand that any software used to diagnose, prevent, or treat a medical condition is considered a “software medical device” and is subject to specific regulations. In the coming blog posts, we’ll delve…