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Regulatory Challenges for Novel Implantable Devices under EU MDR
In the European Union (EU), the Medical Device Regulation (EU MDR) has replaced the Medical Device Directive...
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Clinical Site Selection: Navigating the Complexities of Clinical Trial Success
Selection of an investigational site for a clinical trial is critical to success. Throughout a clinical trial,...
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Applying for Grants to Secure Funding
Preparing and applying for scientific grants can be laborious, time consuming, and laden with hurdles. This is...
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A Quick Guide to the EU IVDR
The In Vitro Diagnostic Directive (EU) 98/79/EC (IVDD) was introduced over two decades ago to establish the...
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The Growth of Digital Health Technology for Patient Reported Outcomes in Clinical Trials
An update to our blog about how digital health technology is optimizing the clinical research industry. Introduction...
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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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