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Advances in Microfluidic Channel Surface Modification for Enhanced Bio-compatibility
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Advances in Microfluidic Channel Surface Modification for Enhanced Bio-compatibility

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Design and Validation of Phantoms for Medical Imaging Devices
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Design and Validation of Phantoms for Medical Imaging Devices

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Noise Reduction and Drift Compensation in Electrochemical and Optical Biosensors
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Noise Reduction and Drift Compensation in Electrochemical and Optical Biosensors

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Batteryless Power Transfer in Implantable IoT Devices: Efficiency, Specific Absorption Rate Safety, and IEC 62304 Considerations
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Batteryless Power Transfer in Implantable IoT Devices: Efficiency, Specific Absorption Rate Safety, and IEC 62304 Considerations

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Accelerated Aging vs. Real-Time Aging: Predictive Correlation for Implantable Devices
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Accelerated Aging vs. Real-Time Aging: Predictive Correlation for Implantable Devices

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Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices
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Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices

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Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights
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Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights

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Navigating Downsizing in the Medical Device Industry: Ensuring Compliance and Operational Continuity with Elexes
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Navigating Downsizing in the Medical Device Industry: Ensuring Compliance and Operational Continuity with Elexes

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FAQs – EU Medical Device Regulation (EU MDR 2017/745)
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FAQs – EU Medical Device Regulation (EU MDR 2017/745)

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Medical Device Testing Requirements: A Complete Guide
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Medical Device Testing Requirements: A Complete Guide

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When is a new 510(k) Submission Required as per the FDA?
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When is a new 510(k) Submission Required as per the FDA?

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What’s New for 510(k) Submissions in 2025? Key Updates and Insights
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What’s New for 510(k) Submissions in 2025? Key Updates and Insights

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Navigating Cybersecurity in Medical Devices: Simplifying Documentation and Compliance
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Navigating Cybersecurity in Medical Devices: Simplifying Documentation and Compliance

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Cybersecurity Standards and Requirements for Medical Devices
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Cybersecurity Standards and Requirements for Medical Devices

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Prevalent Medical Devices In Physical Therapy, Upcoming Innovations and Regulatory Insights 
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Prevalent Medical Devices In Physical Therapy, Upcoming Innovations and Regulatory Insights 

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Medical Devices CE Marking regulations in 2024. What’s New and What’s Changing?
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Medical Devices CE Marking regulations in 2024. What’s New and What’s Changing?

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Why Outsourcing VP of Regulatory and Quality is Essential for Medical Device and IVD Companies Navigating FDA, CE Mark, and Global Compliance
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Why Outsourcing VP of Regulatory and Quality is Essential for Medical Device and IVD Companies Navigating FDA, CE Mark, and Global Compliance

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Why Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies
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Why Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies

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FDA Class II medical devices
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FDA Class II medical devices

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Technological Changes that Call for a New 510k Submission
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Technological Changes that Call for a New 510k Submission

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Medical Device Quality Management System | Why Switch to an Electronic QMS?
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Medical Device Quality Management System | Why Switch to an Electronic QMS?

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Advances in Microfluidic Channel Surface Modification for Enhanced Bio-compatibility
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Advances in Microfluidic Channel Surface Modification for Enhanced Bio-compatibility

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FDA Eliminates a Major Barrier to Using Real-World Evidence in Drug and Device Reviews
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FDA Eliminates a Major Barrier to Using Real-World Evidence in Drug and Device Reviews

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Design and Validation of Phantoms for Medical Imaging Devices
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Design and Validation of Phantoms for Medical Imaging Devices

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FDA’s ASCA Program: Driving Predictability in Standards-Based Medical Device Testing
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FDA’s ASCA Program: Driving Predictability in Standards-Based Medical Device Testing

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Noise Reduction and Drift Compensation in Electrochemical and Optical Biosensors
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Noise Reduction and Drift Compensation in Electrochemical and Optical Biosensors

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FDA Introduces TEMPO Pilot to Accelerate Digital Health for Chronic Diseases
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FDA Introduces TEMPO Pilot to Accelerate Digital Health for Chronic Diseases

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Latest Portfolio

Microfluidic channel with modified surface showing enhanced wettability and reduced protein adsorption

Advances in Microfluidic Channel Surface Modification for Enhanced Bio-compatibility
FDA regulatory review process enhanced by real-world evidence data

FDA Eliminates a Major Barrier to Using Real-World Evidence in Drug and Device Reviews
Tissue-mimicking phantom block with embedded targets used for ultrasound/photoacoustic imaging validation

Design and Validation of Phantoms for Medical Imaging Devices
ASCA program workflow showing standards selection, accredited lab testing, and predictable FDA review

FDA’s ASCA Program: Driving Predictability in Standards-Based Medical Device Testing
Electrochemical biosensor baseline drift and noise correction graph

Noise Reduction and Drift Compensation in Electrochemical and Optical Biosensors
Digital health technology supporting chronic disease management under the FDA’s new TEMPO pilot program.

FDA Introduces TEMPO Pilot to Accelerate Digital Health for Chronic Diseases
Illustration of inductive coupling powering an implantable IoT device through human tissue

Batteryless Power Transfer in Implantable IoT Devices: Efficiency, Specific Absorption Rate Safety, and IEC 62304 Considerations
Medical device workstation in hospital — highlighting cybersecurity and operating system maintenance.

Windows 10 End-of-Support: What Medical Device Manufacturers Must Know
TGA Introduces EU MDR Transition Web Publication Service

TGA Launches EU MDR Transition Web Publication Service: What Manufacturers Need to Know
Accelerated Aging vs Real‐Time Aging for Implantable Devices

Accelerated Aging vs. Real-Time Aging: Predictive Correlation for Implantable Devices
EU Pilot Coordinated Assessment updates

EU Launches Pilot Coordinated Assessment Program for CI/PS: What Medical Device Sponsors Need to Know
Modeling degradation kinetics of biomedical polymers used in implantable medical devices through hydrolysis, oxidation, and Arrhenius-based modeling

Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices
FDA updates Pre-RFD guidance with new recommendations for medical device, drug, and biologic classification.

FDA Issues Revised Pre-RFD Guidance: What Industry Needs to Know
FDA Draft Guidance on QMSR for Premarket Submissions

FDA Issues Draft Guidance on QMSR Information for Premarket Submissions
Notified Bodies Warn Shortage Could Hinder AI Regulation

Notified Bodies Warn Shortage Could Hinder AI Regulation

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