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Three New International Medical Device Software Security Standards Issued By FDA
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Three New International Medical Device Software Security Standards Issued By FDA

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Women is the future of medtech innovations
Elexes Team

Women is the future of medtech innovations

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FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!
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FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!

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

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Extension to EU MDR transition period finalized!
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Extension to EU MDR transition period finalized!

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Opill, an Over-The-Counter (OTC) drug was approved by the US F.D.A.
Elexes Team

Opill, an Over-The-Counter (OTC) drug was approved by the US F.D.A.

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Companion Diagnostics (CDx): The future of safe and effective therapies!
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Companion Diagnostics (CDx): The future of safe and effective therapies!

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Health Canada’s Regulatory requirements for UV light-emitting products with claims pertaining to Covid -19
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Health Canada’s Regulatory requirements for UV light-emitting products with claims pertaining to Covid -19

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3D Medical Imaging | Revolutionizing The Vision of Medicine
Elexes Team

3D Medical Imaging | Revolutionizing The Vision of Medicine

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Addressing Duodenoscope contamination – An FDA Initiative
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Addressing Duodenoscope contamination – An FDA Initiative

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17 years Journey – Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (POP)
Elexes Team

17 years Journey – Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (POP)

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Is EU-MDR coming later? EU MDD to MDR – A major change 
Elexes Team

Is EU-MDR coming later? EU MDD to MDR – A major change 

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Breakthroughs in Cardiovascular Treatments – Where Science becomes the Saviour
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Breakthroughs in Cardiovascular Treatments – Where Science becomes the Saviour

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Explainable AI in Medical Device Signal Processing: A Validation Framework
Team Elexes

Explainable AI in Medical Device Signal Processing: A Validation Framework

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

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

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Statistical Validation of Measurement Uncertainties in Medical Device Metrology
Team Elexes

Statistical Validation of Measurement Uncertainties in Medical Device Metrology

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FDA Class I Recall Highlights Critical Packaging and Sterility Compliance Gaps
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FDA Class I Recall Highlights Critical Packaging and Sterility Compliance Gaps

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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
Team Elexes

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

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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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