Regulatory Affairs2026年4月15日 1 分钟
Home Market Approval ≠ EU Readiness
FDA or NMPA approval doesn't mean EU readiness. Learn why home market success often leads to delays under EU MDR, and how to avoid them.
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Anne-Sophie Grell
PhD Physics, MSc Medical Physics · Business Unit Manager RA MD
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 Affairs2026年3月25日 4 分钟
From R&D to Market: Why the Product Lifecycle Is the Strategic Framework for MedTech
Successful MedTech companies treat product development as a lifecycle strategy. Learn why regulatory planning, IP strategy and development must evolve together.
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Regulatory Affairs2026年3月24日 3 分钟
SaMD Under EU MDR: What Software Developers Need to Know
Developing Software as a Medical Device under EU MDR requires clear intended use, risk classification under Rule 11, and compliance with IEC 62304. Learn what SaMD developers need to know.
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Regulatory Affairs2026年3月23日 4 分钟
IP Strategy for MedTech Startups: What Early-Stage Companies Often Miss
IP strategy should start early in MedTech development. Discover how patent strategy, regulatory classification, and product development influence IP protection for emerging MedTech companies.
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Regulatory Affairs2026年3月22日 5 分钟
EU MDR Compliance for MedTech Startups: What It Really Takes
EU MDR compliance can be challenging for emerging MedTech companies. Learn what MDR actually requires, from qualification and QMS to technical documentation and post-market obligations.
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Regulatory Affairs2026年3月21日 4 分钟
3 Things MedTech Startups Get Wrong About IP & Regulatory Strategy
Many MedTech startups treat IP and regulatory strategy as separate disciplines. Discover the three most common mistakes and how aligning both early strengthens market access and product value.
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Regulatory Affairs2023年2月22日 4 分钟
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 Affairs2021年9月14日 1 分钟
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.
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Regulatory Affairs2021年9月1日 5 分钟
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.
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Regulatory Affairs2021年7月12日 7 分钟
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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