Contact
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

Read More Post a Comment
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

Read More Post a Comment
BS EN ISO 13485:2016/A11:2021
Elexes Team

BS EN ISO 13485:2016/A11:2021

Read More Post a Comment
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

Read More Post a Comment
What does CE Marking imply and why is it required?
Elexes Team

What does CE Marking imply and why is it required?

Read More Post a Comment
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

Read More Post a Comment

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

Need Any Help? Or Looking For an Agent

9806071234
sendmail@example.com
Working Hours : Sun-monday, 09am-5pm
© 2024 Elexes. All Rights Reserved.