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Category: Technical Documentation

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MD/IVD Regulations

IVDR Transition: A Real Test for QA Teams

The IVDR transition is reshaping the EU diagnostics industry. This post explores how QA teams can handle real challenges during implementation—especially for Class B and C IVDs—while staying compliant with UDI, PMS, and performance evaluation requirements.

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Medical Devices

From Chaos to Compliance: Simplifying Technical Documentation for MD & IVDs- Part 2

Learn how to create clear and comprehensive technical documentation for Medical Devices (MD) and In Vitro Diagnostics (IVD). Whether you’re new to the industry or have experience, this guide will help you master the art of technical writing in these fields. Discover the essential practices and expert tips for creating impactful documentation in these critical industries.

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