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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.
Learn how to use ScriptRunner in Jira to streamline and automate internal processes, including traceability, testing, and compliance with ISO 13485, IEC 62304, and FDA 21 CFR Part 11.
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.
Agile development. Practical guidelines for software architecture and software design. Software maintenance process.
Smart Checklist Pro is a tool designed for effective task, project, and process management, directly within platforms like JIRA (or similar systems). It provides a flexible way to create checklists and track progress.
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QMLogic s.r.o is a medical consulting company helping businesses succeed in the medical device industry. We will guide your team through all phases and tasks of the medical device lifecycle, including ISO 13485 , IEC 62304, and Medical Device Regulation.
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