Articles
Agile development. Practical guidelines for software architecture and software design. Software maintenance process.
This article is part of a series on IEC 62304, which focuses on understanding the standard and its correct implementation in medical device software development.
Master medical device software compliance. Understand IEC 62304 software design, detailed design, SOUP, and OTS definitions.
Understand how to classify your medical device under EU MDR 2017/745. This guide explains risk classes, rules, and what you need to bring your product to market — with insights from real-world experience.
Learn the key differences between FDA 510(k) and PMA approval pathways for medical devices in the U.S. and how to choose the right one for your product.
MDSAP is built on ISO 13485, much of what it requires of your electronic QMS is already in place. See the document, record, and training controls it expects.
About Us?
QMLogic is a medical device & IVD consulting and outsourcing company operating as an active partner in building and managing regulatory affairs, quality management, and technical documentation. We support our clients with regulatory activities, QMS digitalization and maintenance, and the preparation of the technical files. Our team ensures full compliance across EU MDR, IVDR, FDA, and relevant international standards.