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.

15 articles

Regulatory AffairsApr 29, 2026 3 min

The Hidden Operational Hurdles of EU Market Entry

CE marking isn't just clinical and regulatory. Discover the hidden operational hurdles that delay EU market entry.

Regulatory AffairsApr 29, 2026 3 min

Why Clinical Strategy Is the Real Bottleneck for EU Market Access

Discover why clinical strategy, not data, is the real bottleneck for EU MDR market access and how to align regulatory and clinical decisions.

Regulatory AffairsApr 29, 2026 3 min

Clinical Evidence Under EU MDR: What Non-EU Manufacturers Get Wrong

Discover what non-EU manufacturers get wrong about clinical evidence under the EU MDR, from CER requirements to PMCF and data reuse.

Regulatory AffairsApr 29, 2026 3 min

The EU Notified Body Process: What Every Non-EU Manufacturer Should Know

Understand the EU Notified Body process for medical devices, from selection to review timelines and common delays under the MDR.

Regulatory AffairsApr 29, 2026 2 min

Why FDA or NMPA Approval Does Not Mean You're Ready for Europe

FDA or NMPA approval doesn't guarantee EU readiness. Discover the key gaps MedTech companies face when transitioning to EU MDR.

Regulatory AffairsApr 15, 2026 1 min

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.

Regulatory AffairsMar 25, 2026 4 min

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.

Regulatory AffairsMar 24, 2026 3 min

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.

Regulatory AffairsMar 23, 2026 4 min

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.

Regulatory AffairsMar 22, 2026 5 min

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.

Regulatory AffairsMar 21, 2026 4 min

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.

Regulatory 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!

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.

Regulatory 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.

Regulatory 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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