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B1+RMS limits on MR Conditional labeling
European notified bodies have recently started requiring B1+RMS limits on MR Conditional labeling. This requirement stems from...
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Navigating Biocompatibility: An Introduction to ISO 10993 Series of Standards
Medical device manufacturers should always refer to ISO 10993 Series of Standards in addition to region-specific regulatory...
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Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions
FDA recently issued a Letter to Industry regarding medical device submissions that contain fraudulent and unreliable third-party...
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3 Steps to MDR/IVDR Compliant Systematic Literature Review
A systematic literature review is a method to collect, identify, and synthesize literature as objectively as possible...
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Failure Analysis Testing
Medical device innovations have greatly improved patient care and outcomes over the past few decades. As we...
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FDA’s New Guidance on Nitrosamine and Nitrosamine- Drug Substance Related Impurities and Recommended Acceptable Intake Limits
The FDA has recently published a Recommended Acceptable Limit guidance document for nitrosamine impurities in drug products....
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Navigating the Complex World of PFAS Regulation for Medical Devices
Per- and poly-fluoroalkyl substances (PFAS) are a group of fluorinated compounds characterized by carbon-fluorine bonds. While some...
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Clinical trial monitoring
Monitoring Clinical trial monitoring is a constantly evolving field, now encompassing various approaches that work together to...
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An important downside to eSTAR
If you are keeping abreast of FDA’s medical device efforts, then you know that as of October...
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Creating a Conference Presentation: All You Need is an Hourglass
Creating an easy to follow, interesting, conference presentation is always the goal of conference attendees, but quite...
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Expanding MR Conditional labeling options using new laboratory equipment
We recently added new equipment to our MRI safety evaluations laboratory that can be used to provide...
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On the Record: Compliance with 21 CFR Part 11 in Clinical Trials
What is 21 CFR Part 11? The United States Code of Federal Regulations (CFR) includes regulations for...
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