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Navigating the 510(k) Submission Process: Basics First
Elexes Team

Navigating the 510(k) Submission Process: Basics First

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Wearables
Elexes Team

Wearables

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Invasive Devices
Elexes Team

Invasive Devices

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Food and Cosmetics
Elexes Team

Food and Cosmetics

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Amit Padhy
Elexes Team

Amit Padhy

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Latest Portfolio

FDA Class I medical device recall highlighting regulatory compliance and patient safety risks

FDA Class I Recall Highlights Critical Packaging and Sterility Compliance Gaps
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

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