Regulatory Strategy & Submissions
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...
The 3 W’s of Regulatory Success: What to Do, When to Do It, and Why It Takes Avania
The regulatory roller coaster of clinical research has always gone through changes — ups and downs, twists and turns. However,...
The MDR Evolution: A Quick Guide to Medical Writing Under New Regulation
For those MedTech innovations sold or exported into Europe, the path to regulatory approval has grown much longer and more...
The MDR Difference: How to Proactively Prepare Your Medical Writing for Tougher Standards
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Podcast: Navigating New MDR Regulation
The MDR: Navigating Europe’s New Standard for Medical Device Safety The more stringent standards of Medical Device Regulation (MDR) demand...