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The US FDA Medical Device User Fee for the Fiscal Year 2022
Elexes Team

The US FDA Medical Device User Fee for the Fiscal Year 2022

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ISO 15223-1:2021 Medical Device Symbols – An indispensable part of labeling
Elexes Team

ISO 15223-1:2021 Medical Device Symbols – An indispensable part of labeling

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BS EN ISO 13485:2016/A11:2021
Elexes Team

BS EN ISO 13485:2016/A11:2021

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

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

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What does CE Marking imply and why is it required?
Elexes Team

What does CE Marking imply and why is it required?

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FDA’s New Requirements: What the MR based Medical Device Manufacturers need to know
Elexes Team

FDA’s New Requirements: What the MR based Medical Device Manufacturers need to know

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Regulatory professionals discussing UDI compliance strategy for medical devices in Australia and preparation for Unique Device Identification requirements.

Unique Device Identification (UDI) Compliance in Australia: Key Steps for Medical Device Manufacturers
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How to Determine if Your Product Requires ARTG Registration Before Medical Device Supply in Australia
TGA software as a medical device regulatory pathway for SaMD entering Australia

Understanding SaMD Regulation in Australia: What TGA’s Clarification Means for Software Medical Device Companies
Regulatory professionals reviewing medical device compliance documents on tablet discussing UK CE recognition and market access strategy.

UK May Indefinitely Recognize CE-Marked Medical Devices: What This Means for Manufacturers
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
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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

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