Introduction: As software developers, our goal is to deliver high-quality products efficiently. One crucial factor that significantly influences our daily work is the implementation of effective Quality Management Systems (QMS) and processes (if you have a such thing in use). In this article, I will explore the positive and negative impacts of QMS and processes […]
Clinical validation is the process of evaluating the clinical performance of a medical device, including its safety and effectiveness, in a real-world setting. This process is particularly important for software medical devices, which can have an impact on patient care. Before a product can be release to public use it has to be clinically validated.
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Safety and effectiveness of the end product are critical for any software medical device. So, it’s important to choose the right project management principles to guide the development process. Based on our pst experience with over 300 different projects we can say that the agile and lean are two of the best project management principles
Why Agile and Lean are the Best Choice for Medical Device Software Development Read More »
While there are many QMS approaches and tools that are commonly used in software development, there are also several principles that are common to many of these approaches. Here are four of the most common QMS principles used in software development: 1. Continuous improvement: This principle involves constantly seeking ways to improve processes and the
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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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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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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
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
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