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.
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Caroline Aernouts
8 articles
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.
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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.
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Regulatory AffairsFeb 18, 2025 1 min
PRRC en el marco del MDR y el IVDR
El Reglamento sobre productos sanitarios (MDR) (UE) 2017/745 y el Reglamento sobre productos sanitarios in vitro (IVDR) (UE) 2017/746 introdujeron una nueva función obligatoria en el artículo 15: la persona responsable del cumplimiento normativo o «PRRC». ¿Te preguntas cuál es el significado del ...
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Regulatory AffairsFeb 17, 2025 1 min
La vía reglamentaria para tu producto sanitario a medida
¿Eres un fabricante de dispositivos médicos hechos a medida y necesitas orientación regulatoria? En este artículo se resumen las principales preocupaciones que se deben tener en cuenta.
Read moreRegulatory 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.
Read moreRegulatory 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.
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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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