Blog on SW development and lean principles

Agile Development EMA FDA JIRA Lean QMS Regulation

  • 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…

    Read more

  • 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…

    Read more