Navigating AI-Enabled Medical Devices: Data, Cybersecurity & CE-Mark Strategy
Artificial Intelligence (AI) is transforming medical devices—from diagnostic algorithms to adaptive therapeutic systems. But bringing an AI-enabled medical device to market in the EU demands more than software development. You must align with the MDR (EU 2017/745),...
Your Path to CE Marking: Building a Solid Foundation with Technical Documentation and Clinical Evaluation
Bringing a medical device to the European market requires more than innovative technology — it demands meticulous documentation and clear evidence of safety and performance. Under the EU Medical Device Regulation (MDR 2017/745), your Technical File and Clinical...
Ensuring Smarter Decisions: Medical Device Due Diligence for Investors and Innovators
In the evolving landscape of health technology, making informed decisions requires more than innovation—it demands strategic insight. Whether you’re an investor evaluating a new opportunity, a startup preparing for funding, or a procurement team assessing a new...
Navigating Medical Device Reimbursement in Germany: What Manufacturers Need to Know
Germany is one of Europe’s largest healthcare markets, but successfully bringing a medical device to German patients requires more than MDR certification. To be competitive, manufacturers must also consider reimbursement pathways early in their market strategy....
Building a Strong Clinical Evaluation: CEP, CER, and the Power of Literature
In the world of medical devices under EU MDR (EU 2017/745), the clinical evaluation process is a cornerstone of demonstrating safety and performance. At its heart are two interlinked documents: the Clinical Evaluation Plan (CEP) - which defines how you’ll gather...
Ensuring Biological Safety with BEP & BER Under MDR — What You Need to Know Now
Biological safety remains a critical part of bringing a medical device to market under EU MDR (EU 2017/745). Two documents in particular matter: the Biological Evaluation Plan (BEP), which lays the groundwork for identifying and managing biological risks; and the...
Leveraging FDA Approval for Global Growth: Strategic Considerations for Medical Device Manufacturers
For many medical device companies, the United States is not only one of the largest healthcare markets in the world—it’s also a gateway to global opportunities. FDA clearance or approval is widely recognized as a gold standard in medical device regulation, and...
Navigating Regulatory Pathways: FDA vs. EU-MDR Explained
When bringing a medical device to market, one of the most important strategic choices manufacturers face is deciding whether to pursue approval in the United States under the FDA or in the European Union under the EU-MDR. Both frameworks are globally respected, but...
From First Patient to Final Report: How CRO Expertise Ensures Quality and Compliance
Once your clinical investigation is underway, the focus shifts from planning and preparation to execution, oversight, and data integrity. This stage is where the evidence needed for MDR (EU 2017/745) compliance—and ultimately market approval—is gathered, validated,...
From Planning to First Patient: How Early-Phase CRO Support Sets Your Clinical Investigation Up for Success
While the past weeks have been quieter on our blog, our work behind the scenes has been as active as ever—supporting medical device companies in planning, managing, and executing clinical investigations. Now that the vacation season is winding down, we’re kicking...
