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Is your medical device 510(k) exempt? Understanding the classification of medical devices!
Elexes Team

Is your medical device 510(k) exempt? Understanding the classification of medical devices!

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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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Postmarket Surveillance: An inescapable sound of noise
Elexes Team

Postmarket Surveillance: An inescapable sound of noise

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Access to De Novo Summaries – A treasure for manufacturers
Elexes Team

Access to De Novo Summaries – A treasure for manufacturers

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CLIA Database: A Centralized Database of Clinical Tests & Instruments
Elexes Team

CLIA Database: A Centralized Database of Clinical Tests & Instruments

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De Novo paving the path for Technological Advancements
Elexes Team

De Novo paving the path for Technological Advancements

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The Harmonized ISO 13485 | For Which countries its applicable?
Elexes Team

The Harmonized ISO 13485 | For Which countries its applicable?

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IEC 60601-1 (Electrical Safety Standards) | Know All About It!
Elexes Team

IEC 60601-1 (Electrical Safety Standards) | Know All About It!

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Know It All About FDA Medical Devices Advisory Committee
Elexes Team

Know It All About FDA Medical Devices Advisory Committee

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IMPORT/EXPORT-U.S: Expand your boundaries
Elexes Team

IMPORT/EXPORT-U.S: Expand your boundaries

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Know The Differences For Proactive Planning | From MDD to MDR!
Elexes Team

Know The Differences For Proactive Planning | From MDD to MDR!

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List of Essential Components for Clinical Evaluation Report!
Elexes Team

List of Essential Components for Clinical Evaluation Report!

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Importance of Well Designed DHF Remediation!
Elexes Team

Importance of Well Designed DHF Remediation!

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CER Challenges That Lead To Non-Compliance!
Elexes Team

CER Challenges That Lead To Non-Compliance!

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De Novo: A Propeller for Innovation in the Medical Device Regulatory Framework
Elexes Team

De Novo: A Propeller for Innovation in the Medical Device Regulatory Framework

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510(k) Premarket Notification – A Passport for Market Entry
Elexes Team

510(k) Premarket Notification – A Passport for Market Entry

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Can Wearable Devices Compete With Hospital Capital Equipments?
Elexes Team

Can Wearable Devices Compete With Hospital Capital Equipments?

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510(k) Decision making flowchart | Understand the entire process
Elexes Team

510(k) Decision making flowchart | Understand the entire process

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Navigating the 510(k) Submission Process: Basics First
Elexes Team

Navigating the 510(k) Submission Process: Basics First

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Wearables
Elexes Team

Wearables

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Invasive Devices
Elexes Team

Invasive Devices

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When is a new 510(k) Submission Required as per the FDA?
Team Elexes

When is a new 510(k) Submission Required as per the FDA?

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What’s New for 510(k) Submissions in 2025? Key Updates and Insights
Team Elexes

What’s New for 510(k) Submissions in 2025? Key Updates and Insights

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Navigating Cybersecurity in Medical Devices: Simplifying Documentation and Compliance
Team Elexes

Navigating Cybersecurity in Medical Devices: Simplifying Documentation and Compliance

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Cybersecurity Standards and Requirements for Medical Devices
Team Elexes

Cybersecurity Standards and Requirements for Medical Devices

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Prevalent Medical Devices In Physical Therapy, Upcoming Innovations and Regulatory Insights 
Team Elexes

Prevalent Medical Devices In Physical Therapy, Upcoming Innovations and Regulatory Insights 

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Medical Devices CE Marking regulations in 2024. What’s New and What’s Changing?
Team Elexes

Medical Devices CE Marking regulations in 2024. What’s New and What’s Changing?

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Latest Portfolio

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
EU Pilot Coordinated Assessment updates

EU Launches Pilot Coordinated Assessment Program for CI/PS: What Medical Device Sponsors Need to Know
Modeling degradation kinetics of biomedical polymers used in implantable medical devices through hydrolysis, oxidation, and Arrhenius-based modeling

Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices
FDA updates Pre-RFD guidance with new recommendations for medical device, drug, and biologic classification.

FDA Issues Revised Pre-RFD Guidance: What Industry Needs to Know
FDA Draft Guidance on QMSR for Premarket Submissions

FDA Issues Draft Guidance on QMSR Information for Premarket Submissions

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