Caroline Aernouts

6 articles

Regulatory AffairsSep 4, 2025 2 min

PMCF: How QbD Group Helps You Master MDR Compliance from Plan to Report

Discover how QbD supports MDR compliance with strategic PMCF planning, execution, and documentation, from plan to report.

Regulatory AffairsJul 23, 2025 1 min

Usability Testing and MDR: Managing Risk with the Human Factor

Usability testing plays a key role in MDR compliance. Learn how early, structured testing helps reduce risk, improve device safety, and support regulatory approval.

Regulatory AffairsJul 23, 2025 1 min

In-Silico Testing & MDR: Smarter Evidence, Not Optional Evidence

Discover how in-silico testing supports MDR compliance. Learn how simulations can strengthen your clinical evaluation and reduce reliance on animal or human testing.

Regulatory AffairsJun 30, 2022 1 min

The regulatory pathway for your custom-made medical device

Are you a manufacturer of custom-made medical devices and in need of regulatory guidance? This post summarizes key concerns to consider.

Regulatory AffairsJun 9, 2022 1 min

PRRC under MDR and IVDR: meaning, requirements, and responsibilities

MDR and IVDR introduced a new obligatory role. Find out more about the PRRC's meaning, requirements, and responsibilities here.

Regulatory AffairsSep 5, 2021 1 min

Unraveling Artificial Intelligence in Medical Devices: what do we know so far?

Artificial Intelligence is the IT word in Medical Devices nowadays. Learn more on AI and its regulatory implications for manufacturers.

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