Regulatory AffairsFeb 19, 2025 8 min
¿Qué es un producto sanitario?
¿Es tu producto un producto sanitario? Depende de los mercados en los que quieras entrar y de su normativa. He aquí un resumen para orientarte.
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Anne-Sophie Grell
PhD Physics, MSc Medical Physics · Manager Regulatory Affairs – Medical Devices
Anne-Sophie is a Regulatory Affairs leader with over two decades of experience in medical physics, diagnostic imaging, and medical device regulation. She supports clients navigating EU MDR, FDA, and international regulatory frameworks.
Regulatory AffairsFeb 18, 2025 1 min
SaMD frente a MDSW: ¿cuál es la diferencia?
Los términos SaMD (Software as a Medical Device) y MDSW (Medical Device SoftWare) a menudo se usan indistintamente dentro de los entornos médicos, pero no lo son. Conoce la diferencia de significado y alcance regulatorio aquí..
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Software Solutions & ServicesFeb 14, 2025 5 min
UDI para software: ¿cómo marcar tu MDSW con un UDI?
Cada dispositivo médico individual debe tener un Identificador Único de Dispositivo (UDI) con su portador (código de barras o código QR). Pero, ¿qué pasa con el software de dispositivos médicos? ¡Lee la respuesta en este artículo!
Read moreRegulatory AffairsFeb 22, 2023 4 min
UDI for software: how to mark your MDSW with a UDI?
Each medical device needs a Unique Device Identifier (UDI) with a barcode or QR code. But what about medical device software? Find out in this article!
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Regulatory AffairsSep 14, 2021 1 min
MDR impact on MDSW: what has changed from MDD?
The introduction of MDR impacts CE-marked medical software (MDSW). Curious about the scope of this impact on your software? Read more here.
Read moreRegulatory AffairsSep 1, 2021 5 min
SaMD versus MDSW: what’s the difference between Software as a Medical Device and Medical Device SoftWare?
The terms SaMD (Software as a Medical Device) and MDSW (Medical Device SoftWare) are often used interchangeably within medical environments, but they are not. Learn the difference in meaning and regulatory scope here.
Read moreRegulatory AffairsJul 12, 2021 7 min
What is a medical device? Key definitions and regulations around the world.
Is your product a medical device? Well, that depends on the markets you want to enter and their regulations. Here's an overview to guide you.
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