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Recent Posts

Importing and Supplying Medical Devices in Australia: What the January 2026 TGA Update Means for Manufacturers and Sponsors

Importing and Supplying Medical Devices in Australia: What the January 2026 TGA Update Means for Manufacturers and Sponsors

Explainable AI in Medical Device Signal Processing: A Validation Framework

Explainable AI in Medical Device Signal Processing: A Validation Framework

FDA Final General Wellness Policy: What It Means for Health Tech Companies

FDA Final General Wellness Policy: What It Means for Health Tech Companies

Statistical Validation of Measurement Uncertainties in Medical Device Metrology

Statistical Validation of Measurement Uncertainties in Medical Device Metrology

FDA Class I Recall Highlights Critical Packaging and Sterility Compliance Gaps

FDA Class I Recall Highlights Critical Packaging and Sterility Compliance Gaps

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Latest Portfolio

Importing and supplying medical devices under Australian TGA regulations

Importing and Supplying Medical Devices in Australia: What the January 2026 TGA Update Means for Manufacturers and Sponsors
Medical device signal waveform with AI interpretability feature attribution overlay

Explainable AI in Medical Device Signal Processing: A Validation Framework
FDA General Wellness Policy impact on health wearable devices and wellness applications

FDA Final General Wellness Policy: What It Means for Health Tech Companies
Medical device calibration rig showing sensor measurement and uncertainty analysis in metrology laboratory

Statistical Validation of Measurement Uncertainties in Medical Device Metrology
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

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