Regulatory Strategy & Submissions
Avania IVD Solutions: A Fully Integrated Approach to Diagnostics Product Strategy
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The EU’S AI Act: Navigating the New Landscape of Artificial Intelligence Regulation in Medical Device ResearchÂ
Artificial intelligence (AI) has become an integral part of our daily lives, influencing everything from personal devices to large-scale industrial...
The Era of MDR & IVDR Evaluation: How Our CER Framework Accelerates Medical Writing
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5 Ways to Find MedTech Global Market Efficiencies Now
Pursuing market approval for medical devices that will be used in both the EU and the U.S. is more complex...
3 Absolute Essentials of IVDR Implementation: A Closer Look at the Biggest Changes
The transition from the In Vitro Diagnostic Medical Device Directive (IVDD) to the In Vitro Diagnostic Medical Device Regulation (IVDR)...
What Defines SaMD Success? The 3 Simple Steps of MedTech Software Development
Famous railroad executive Alfred Perlman once wrote, “After you’ve done a thing the same way for two years, look it...
The Next STeP for Your Medical Device: How to Utilize the FDA’s Safer Technologies Program
The Safer Technologies Program (STeP) is a voluntary program for medical devices and combination products expected to improve the safety...
Understanding IVDR: Insights and Implementation
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EU MDR Transition Period Extension Effective From March 20, 2023, Onward
The Medical Device Regulation (MDR 2017/745) came into force on May 26, 2021. The transition period for CE certificates issued...
A Guide to Choosing the Right EDC for Your Clinical Study
Electronic data capture (EDC) is the most common method of data collection in clinical trials. While each system serves to...