Medical Devices
Avania IVD Solutions: A Fully Integrated Approach to Diagnostics Product Strategy
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The Secret to Site Selection: How CMS Data Enhance Medical Device Research
Site selection is stressful. It’s tricky to find and choose research sites that both meet your clinical trial’s qualifications and...
Important Regulation Update: FDA’s Cybersecurity in Medical Devices Guidance
The FDA has issued the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance that includes...
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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Successful Market Access of SaMD & MDSW: Decoding the Confusion in MedTech Software Development
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