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Demystifying the De Novo Process - Featured Image

Demystifying the De Novo Process

How do you navigate the De Novo process for your medical device? When do you decide to go that route...
Explaining UDI Requirements for GUDID and EUDAMED - Featured Image

Explaining UDI Requirements for GUDID and EUDAMED

Recent numbers from the World Health Organization indicate there are at least 2 million different ty...
Navigating the Medical Device Single Audit Program (MDSAP) - Featured Image

Navigating the Medical Device Single Audit Program (MDSAP)

Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory require...
3 Common Misconceptions About Medical Device Packaging - Featured Image

3 Common Misconceptions About Medical Device Packaging

If you asked people what comes to mind when you say designing a medical device, you’re likely going ...
Making Your Informational Meetings with FDA Valuable & Worthwhile - Featured Image

Making Your Informational Meetings with FDA Valuable & Worthwhile

What are informational meetings with the FDA, why should you schedule them, and how should they be c...
QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices - Featured Image

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the in...
QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies - Featured Image

QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulatio...
Your Device is Non-Significant Risk: Now What? - Featured Image

Your Device is Non-Significant Risk: Now What?

If you need to conduct a clinical investigation of your device before it has received market approva...
A Regulatory Gap Analysis of FDA's Systems & Policies - Featured Image

A Regulatory Gap Analysis of FDA's Systems & Policies

What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improv...
How Do FDA Medical Device Recalls Work? - Featured Image

How Do FDA Medical Device Recalls Work?

For medical device companies, few things are as valuable as the public’s trust.
Tips For Being Prepared Post-EUA (Emergency Use Authorization) - Featured Image

Tips For Being Prepared Post-EUA (Emergency Use Authorization)

Does your company have products that were granted emergency use authorization to get to market? Assu...
Cytotoxicity Testing: Ensuring the Biocompatibility of Your Medical Device - Featured Image

Cytotoxicity Testing: Ensuring the Biocompatibility of Your Medical Device

Biocompatibility testing is one of the fundamental means of ensuring medical devices are safe for pa...

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