<?xml version="1.0" encoding="UTF-8"?><rss version="2.0"><channel><title>MedTech.blog</title><link>https://medtech.blog</link><description>Practical guidance for safe, secure and regulator-ready medical devices.</description><language>en-GB</language><item><title><![CDATA[The practical guide to developing a medical device]]></title><link>https://medtech.blog/articles/practical-guide-medical-device-development</link><guid>https://medtech.blog/articles/practical-guide-medical-device-development</guid><pubDate>Sun, 23 Aug 2026 00:00:00 GMT</pubDate><description><![CDATA[An end-to-end view of medical-device development, from intended purpose and user needs through verification, validation, transfer and maintenance.]]></description></item><item><title><![CDATA[Design controls: from user need to objective evidence]]></title><link>https://medtech.blog/articles/design-controls-user-needs-to-evidence</link><guid>https://medtech.blog/articles/design-controls-user-needs-to-evidence</guid><pubDate>Sun, 23 Aug 2026 00:00:00 GMT</pubDate><description><![CDATA[How user needs, requirements, design outputs, risk controls, verification and validation form a coherent evidence chain.]]></description></item><item><title><![CDATA[Why an FMEA is not a complete product risk analysis]]></title><link>https://medtech.blog/articles/fmea-not-complete-risk-analysis</link><guid>https://medtech.blog/articles/fmea-not-complete-risk-analysis</guid><pubDate>Sun, 23 Aug 2026 00:00:00 GMT</pubDate><description><![CDATA[Understand where FMEA helps, what it misses and how to integrate it into a complete medical-device risk-management process.]]></description></item><item><title><![CDATA[IEC 62304 and the medical-device software lifecycle]]></title><link>https://medtech.blog/articles/iec-62304-software-lifecycle</link><guid>https://medtech.blog/articles/iec-62304-software-lifecycle</guid><pubDate>Sun, 23 Aug 2026 00:00:00 GMT</pubDate><description><![CDATA[A practical introduction to IEC 62304, software safety classification and the evidence created across development and maintenance.]]></description></item><item><title><![CDATA[Medical-device cybersecurity: an integrated lifecycle approach]]></title><link>https://medtech.blog/articles/integrated-medical-device-cybersecurity</link><guid>https://medtech.blog/articles/integrated-medical-device-cybersecurity</guid><pubDate>Sun, 23 Aug 2026 00:00:00 GMT</pubDate><description><![CDATA[How to integrate cybersecurity governance and evidence across the complete medical-device lifecycle.]]></description></item><item><title><![CDATA[Verification and validation: what is the difference?]]></title><link>https://medtech.blog/articles/verification-versus-validation</link><guid>https://medtech.blog/articles/verification-versus-validation</guid><pubDate>Sun, 23 Aug 2026 00:00:00 GMT</pubDate><description><![CDATA[A clear explanation of verification, validation and how both connect to user needs, design inputs and objective evidence.]]></description></item><item><title><![CDATA[Primary functions, essential performance and safety-related requirements]]></title><link>https://medtech.blog/articles/primary-functions-essential-performance</link><guid>https://medtech.blog/articles/primary-functions-essential-performance</guid><pubDate>Sun, 23 Aug 2026 00:00:00 GMT</pubDate><description><![CDATA[A practical framework for distinguishing device functions, essential performance, safety-related requirements and supporting quality attributes.]]></description></item><item><title><![CDATA[Building an audit-ready design history file]]></title><link>https://medtech.blog/articles/audit-ready-design-history-file</link><guid>https://medtech.blog/articles/audit-ready-design-history-file</guid><pubDate>Sun, 23 Aug 2026 00:00:00 GMT</pubDate><description><![CDATA[What makes development evidence coherent, reviewable and defensible before an audit or submission.]]></description></item></channel></rss>