Blog on SW development and lean principles

Agile Development EMA FDA JIRA Lean QMS Regulation

  • Clinical validation for a software medical device

    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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  • Why Agile and Lean are the Best Choice for Medical Device Software Development

    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 …

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  • The Most Common Quality Management Systems Used in Software Development

    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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  • 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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