What Is EU MDR and How Can Digital Health Companies Navigate It?
The European Union Medical Device Regulation (EU MDR) is one of the most important regulatory frameworks affecting medical device and digital health companies today. If your product qualifies as a medical device in Europe, understanding EU MDR is essential for market access. For digital health and Software as a Medical Device (SaMD) companies, EU MDR…
ISO 13485 vs ISO 9001: Key Differences Explained
When organizations start building a quality management system, a common question appears early: ISO 13485 vs ISO 9001 — what’s the difference, and which one should you use? Both standards focus on quality management, but they serve different purposes and industries. Understanding how they compare is essential for choosing the right framework, especially for companies…
ISO 9001 Quality Manual: What It Is and How to Create One
An ISO 9001 quality manual is a document that describes how an organization’s Quality Management System (QMS) is structured and how it meets ISO 9001 requirements. Although ISO 9001:2015 no longer makes a quality manual mandatory, many organizations still use one because it provides clarity, structure, and a single reference point for their quality system.…
How Many Clauses Are There in ISO 9001? (Complete Breakdown)
If you’re new to quality management systems, one of the first questions you might ask is: How many clauses are there in ISO 9001? The short answer: ISO 9001:2015 contains 10 main clauses. However, only clauses 4 through 10 contain auditable requirements. The first three clauses provide background and context. Understanding how these clauses are…
What Is ISO 13485? A Guide for Digital Health and AI Medical Device Companies
As digital health and AI-enabled medical devices become more common, regulatory expectations are increasing. Whether you are developing clinical decision support software, diagnostic AI, or remote monitoring tools, you will need a structured ISO 13485-aligned quality management system. ISO 13485 is the international quality management system standard specifically designed for medical device companies. It plays…
What Has Changed in 510(k) Submissions for AI-Enabled Medical Devices?
From imaging analysis to clinical decision support, AI is improving how devices detect, diagnose, and monitor disease. As these technologies mature, the U.S. Food and Drug Administration has updated its expectations for how AI-enabled medical devices are reviewed under the 510(k) pathway. The 510(k) pathway remains one of the most common routes to market for…
Does Your Company Really Need a QMS Software?
Short answer: No, you don’t need a QMS software. Long answer: Not at the beginning and not for the reasons most vendors claim. Quality Management System (QMS) software has become a standard recommendation for medical device and digital health companies. Many teams assume they need tools like electronic QMS platforms immediately. In reality, the decision…
FDA 510(k) vs EU MDR for digital health
FDA 510(k) vs EU MDR. If you’re building a digital health product, you will almost certainly face this question early: Should we go through FDA 510(k), EU MDR CE marking, or both? The answer isn’t just regulatory, it’s strategic. The FDA and EU MDR take fundamentally different approaches to software, evidence, and approval. Understanding those…
Software as a Medical Device: Where Code Meets Regulation
From diagnostic algorithms and clinical decision support tools to AI-driven monitoring platforms, Software as a Medical Device (SaMD) is reshaping healthcare—and regulators are paying very close attention. Software doesn’t just support medical devices anymore.In many cases, the software is the medical device. This blog exists to make sense of that regulatory landscape. Why “Software as…