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Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Elexes Team

Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…

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Intended Use vs Indications for Use – FDA Definitions and Submission Impact
Elexes Team

Intended Use vs Indications for Use – FDA Definitions and Submission Impact

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Determining Whether Your Product is a Medical Device! (FDA Medical Device Classification)
Elexes Team

Determining Whether Your Product is a Medical Device! (FDA Medical Device Classification)

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A Final Guidances On Device Shortage Reporting & Computational Modeling Published By FDA
Team Elexes

A Final Guidances On Device Shortage Reporting & Computational Modeling Published By FDA

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The Top 10 Challenges Faced By Medical Device Manufacturers!
Elexes Team

The Top 10 Challenges Faced By Medical Device Manufacturers!

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Abbreviated New Drug Application (ANDA): What it is, How it Works?
Elexes Team

Abbreviated New Drug Application (ANDA): What it is, How it Works?

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Latest Portfolio

FDA quality management system regulation impact on medical device manufacturers.

QMSR Compliance Timeline: How to Prepare Before FDA Enforcement Begins
Medical device regulatory documentation for ultrasound systems

Health Canada Clarifies Device Licence Requirements for Diagnostic Ultrasound Systems
Thermal simulation heat map of a high-power laser medical device heat sink and in-tissue thermal measurement during dermatologic treatment

Thermal Management and Bio-Safety of High-Power Laser-Based Medical Devices
UK clinical trial reform enabling faster medical device and IVD studies

Implications for Medical Device & IVD Clinical Evidence Strategy
Cross-section of MEMS pressure sensor package showing micro-crack initiation after sterilization

Failure Mode Patterns in MEMS Pressure Sensors under Sterilization and Long-Term Use
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

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