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MDSAP Audit | Complete Guide!
Elexes Team

MDSAP Audit | Complete Guide!

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Importance of regulatory strategy
Elexes Team

Importance of regulatory strategy

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HIPAA Law Violations & Their Serious Consequences
Elexes Team

HIPAA Law Violations & Their Serious Consequences

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Navigating the Regulatory Landscape: Challenges and Opportunities for Medical Device and IVD Startups
Elexes Team

Navigating the Regulatory Landscape: Challenges and Opportunities for Medical Device and IVD Startups

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13 Common Mistakes to Avoid in the 510(k) Submission
Elexes Team

13 Common Mistakes to Avoid in the 510(k) Submission

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510K Submission | How To Pass Through FDA’s “Refuse to Accept” Policy!
Elexes Team

510K Submission | How To Pass Through FDA’s “Refuse to Accept” Policy!

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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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Top 5 Common Mistakes to Avoid in the 510(k) Submission
Elexes Team

Top 5 Common Mistakes to Avoid in the 510(k) Submission

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HIPAA Law Violations Types, Examples & How to Avoid Them
Elexes Team

HIPAA Law Violations Types, Examples & How to Avoid Them

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Staying Ahead of the Game: A Comprehensive Guide in Navigating the EU MDR
Elexes Team

Staying Ahead of the Game: A Comprehensive Guide in Navigating the EU MDR

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MDR Extension: Navigating the Latest Changes in European Medical Device Regulations
Elexes Team

MDR Extension: Navigating the Latest Changes in European Medical Device Regulations

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Canadian Regulations for Medical Device Manufacturers and Importers
Parul Chansoria

Canadian Regulations for Medical Device Manufacturers and Importers

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What is so special about Harmonised Standards for medical devices and IVDs?
Elexes Team

What is so special about Harmonised Standards for medical devices and IVDs?

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Change is inevitable – The dynamic world of Medical Device Standards and compliance
Elexes Team

Change is inevitable – The dynamic world of Medical Device Standards and compliance

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Refuse to Accept – An important milestone for your device during the FDA review process
Elexes Team

Refuse to Accept – An important milestone for your device during the FDA review process

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Common pitfalls during the CE marking of a Medical Device or IVD
Elexes Team

Common pitfalls during the CE marking of a Medical Device or IVD

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LDTs vs. IVDs: Understanding FDA’s New Guidelines and Their Impact
Elexes Team

LDTs vs. IVDs: Understanding FDA’s New Guidelines and Their Impact

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All you need to know about a Premarket Approval (PMA) Submission — Route to the US Market for Class III medical devices
Elexes Team

All you need to know about a Premarket Approval (PMA) Submission — Route to the US Market for Class III medical devices

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A to Z of a Clinical Evaluation Report
Elexes Team

A to Z of a Clinical Evaluation Report

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Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices
Team Elexes

Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices

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FDA Issues Revised Pre-RFD Guidance: What Industry Needs to Know
Team Elexes

FDA Issues Revised Pre-RFD Guidance: What Industry Needs to Know

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FDA Issues Draft Guidance on QMSR Information for Premarket Submissions
Team Elexes

FDA Issues Draft Guidance on QMSR Information for Premarket Submissions

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Notified Bodies Warn Shortage Could Hinder AI Regulation
Team Elexes

Notified Bodies Warn Shortage Could Hinder AI Regulation

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MHRA Plans Risk-Proportionate AI and Medical Device Oversight
Team Elexes

MHRA Plans Risk-Proportionate AI and Medical Device Oversight

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MedTech Industry Urges Comprehensive Reforms to MDR and IVDR
Team Elexes

MedTech Industry Urges Comprehensive Reforms to MDR and IVDR

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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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