Medical Device Regulatory & Engineering Blog

A design freeze is a critical milestone in medical device development where the design is declared complete, documented, reviewed, and locked against uncontrolled changes. At ...

Design control is the foundation of medical device regulatory compliance. Under FDA 21 CFR Part 820.30, every manufacturer must establish and maintain procedures for the ...

ISO 14971 risk management for medical devices is a closed loop that runs from a written plan to post-market monitoring, for the whole life of ...

Inadequate distinction between Design Verification and Design Validation frequently leads to regulatory rejection. This guide addresses that gap by defining the engineering rigour required for ...

Electronic instructions for use (eIFU) under EU Regulation 2025/1234 are now open to every medical device intended for professional users. Short answer: since 16 July ...

Luxembourg — December 15, 2025 — Matrix One, a leading digital solution provider for the medical devices and life sciences industry and backed by Lauxera ...

28 May 2026. After that date, EUDAMED will reject any new device registration that lacks a valid, publicly accessible eIFU URL — no grace period, ...

In the world of medical device software, compliance often feels like a maze of documents, checklists, and reviews. But when it comes to IEC 62304, ...

Designing a safe and effective medical device starts with clarity. Before development even begins, you need a deep understanding of your users and a structured ...