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Regulatory Affairs Blog Posts

July 22, 2021 Regulatory Affairs

The Human Factor – Preparing Your Device for Usability Testing

Usability studies that take the "human factor" into consideration are essential for…

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July 12, 2021 Regulatory Affairs

Pedaling While Fixing a Flat: Conducting a Good FDA Meeting...

Before using a significant risk medical device in a clinical study, Sponsors…

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July 1, 2021 Regulatory Affairs

Former Deputy Director of Diagnostics, Bill and Melinda Gates Foundation,...

Dr. Giachetti’s extensive experience managing complex diagnostics programs make her a valuable…

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June 28, 2021 Regulatory Affairs

45 Years of 510(k) Submissions: FDA Celebrates with Improvements to...

FDA is working to bring life-saving devices to market as quickly as…

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June 22, 2021 Regulatory Affairs

Understanding Cybersecurity Threats to Medical Devices

In this post, we talk about medical device cybersecurity, FDA's pre-market and…

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June 17, 2021 Regulatory Affairs

How to File Post-Approval Changes to an NDA or ANDA

The range of variables and decisions that go into changing a previously…

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June 9, 2021 Regulatory Affairs

United in Diversity: Six Tips for European Batch Release

Navigating the regulatory landscape can be challenging, but implementing these tips will…

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June 7, 2021 Regulatory Affairs

Meet the Expert: Anchal Choudhuri

Our “Meet the Expert” series introduces you to our team of experts…

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