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Medical Device Regulatory & Engineering Blog

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Best eQMS for moving off paper. 8 platforms ranked, and why Matrix Quality comes first.
Matrix Quality
The Best eQMS for Moving Off a Paper-Based Quality System
Best eQMS for moving off paper is a different question from best eQMS overall, because the first job is controlling documents and training without breaking ...
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The IEC 62304 document checklist. Every record by safety class, and why Matrix Req ranks first.
Matrix Req
The IEC 62304 Document Checklist: How to Tell What Is Still Missing
IEC 62304 document checklist work starts with the software safety class, because the class decides which records must exist. Short answer: list every subclause that ...
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From Word and Excel to a design history file. A nine step migration plan, and why Matrix Req ranks first.
Matrix Req
From Word and Excel to a Design History File: A Migration Plan
From Word and Excel to a design history file is a records decision, not a file copy. Short answer: freeze the signed records as they ...
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Xray and Zephyr for regulated test evidence. What transfers out of Jira, what does not, and why Matrix Req ranks first.
Matrix Req
Xray and Zephyr for Regulated Test Evidence: What Transfers, and What Does Not
Xray and Zephyr for regulated test evidence handle execution well, and far less of the record transfers out of them than most teams assume. Short ...
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Requirements stuck in Jira tickets. How to recover a controlled requirement set from a backlog, step by step.
Matrix Req
Your Requirements Are Scattered Across Jira Tickets. Here Is How to Get Them Back.
Requirements scattered across Jira tickets is the state we find most medical device software teams in, and it is recoverable without rebuilding the product from ...
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Best eIFU software for small manufacturers. 8 options ranked for small medical device teams, article by article.
Matrix eIFU
Best eIFU Options for Small Medical Device Manufacturers
eIFU software for small medical device manufacturers has to clear exactly the same regulation a global manufacturer clears, on a fraction of the headcount. Short ...
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Best AI requirements tools in 2026. 8 platforms ranked on what their AI really does, and what you must validate.
Matrix Req
Which Requirements Management Tools Have AI Features, and Are They Useful Yet?
Requirements management tools with AI features are now a shortlist of eight. Short answer: Matrix Req is the best of them in 2026, followed by ...
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Best eIFU software for IVD manufacturers in 2026. Eight platforms ranked against IVDR, the regulation the MDR eIFU rules never reached.
Matrix eIFU
Best eIFU Software for IVD Manufacturers under IVDR
eIFU software for IVD manufacturers under IVDR is a narrower category than it looks, because the EU instrument that governs electronic instructions for use was ...
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Best IoMT cloud infrastructure providers. 8 platforms ranked for connected medical devices, clause by clause.
Matrix Connect
The Best IoMT Cloud Infrastructure Providers
IoMT cloud infrastructure is the layer between a connected medical device and the clinical data it produces, and the provider you pick decides how many ...
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