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.

10 articles

Regulatory Affairs15 abr 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 Affairs25 mar 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 Affairs24 mar 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 Affairs23 mar 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 Affairs22 mar 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 Affairs21 mar 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 Affairs22 feb 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 Affairs14 sept 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 Affairs1 sept 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 Affairs12 jul 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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