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Windows 10 End-of-Support: What Medical Device Manufacturers Must Know
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Windows 10 End-of-Support: What Medical Device Manufacturers Must Know

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TGA Launches EU MDR Transition Web Publication Service: What Manufacturers Need to Know
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TGA Launches EU MDR Transition Web Publication Service: What Manufacturers Need to Know

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EU Launches Pilot Coordinated Assessment Program for CI/PS: What Medical Device Sponsors Need to Know
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EU Launches Pilot Coordinated Assessment Program for CI/PS: What Medical Device Sponsors Need to Know

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FDA Issues Draft Guidance on QMSR Information for Premarket Submissions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FDA Issues Draft Guidance on QMSR Information for Premarket Submissions

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Notified Bodies Warn Shortage Could Hinder AI Regulation
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Notified Bodies Warn Shortage Could Hinder AI Regulation

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

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MedTech Industry Urges Comprehensive Reforms to MDR and IVDR
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MedTech Industry Urges Comprehensive Reforms to MDR and IVDR

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FDA Seeks Feedback on Real-World Performance of AI Medical Devices
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FDA Seeks Feedback on Real-World Performance of AI Medical Devices

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FDA’s ASCA Program: Transforming Medical Device Compliance
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FDA’s ASCA Program: Transforming Medical Device Compliance

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QMSR Final Rule Issued by FDA with 2-years Transition Period
Elexes Team

QMSR Final Rule Issued by FDA with 2-years Transition Period

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FDA Issues First Mass Drug Imports To States From Canada
Elexes Team

FDA Issues First Mass Drug Imports To States From Canada

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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!
Elexes Team

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!
Elexes Team

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
Elexes Team

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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Batteryless Power Transfer in Implantable IoT Devices: Efficiency, Specific Absorption Rate Safety, and IEC 62304 Considerations
Team Elexes

Batteryless Power Transfer in Implantable IoT Devices: Efficiency, Specific Absorption Rate Safety, and IEC 62304 Considerations

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Windows 10 End-of-Support: What Medical Device Manufacturers Must Know
Team Elexes

Windows 10 End-of-Support: What Medical Device Manufacturers Must Know

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TGA Launches EU MDR Transition Web Publication Service: What Manufacturers Need to Know
Team Elexes

TGA Launches EU MDR Transition Web Publication Service: What Manufacturers Need to Know

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Accelerated Aging vs. Real-Time Aging: Predictive Correlation for Implantable Devices
Team Elexes

Accelerated Aging vs. Real-Time Aging: Predictive Correlation for Implantable Devices

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EU Launches Pilot Coordinated Assessment Program for CI/PS: What Medical Device Sponsors Need to Know
Team Elexes

EU Launches Pilot Coordinated Assessment Program for CI/PS: What Medical Device Sponsors Need to Know

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

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Latest Portfolio

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
Notified Bodies Warn Shortage Could Hinder AI Regulation

Notified Bodies Warn Shortage Could Hinder AI Regulation
MHRA CEO Highlights Risk-Proportionate Regulation for AI & Medical Devices

MHRA Plans Risk-Proportionate AI and Medical Device Oversight
MedTech industry experts discussing proposed reforms to MDR and IVDR regulations.

MedTech Industry Urges Comprehensive Reforms to MDR and IVDR
Illustration showing AI technology and FDA evaluation concept for medical devices

FDA Seeks Feedback on Real-World Performance of AI Medical Devices
FDA’s ASCA program helps medical device makers streamline compliance and submissions.

FDA’s ASCA Program: Transforming Medical Device Compliance
AI and regulatory trends shaping the future of inflammation imaging in healthcare

Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights
MedTech downsizing guidance ensuring compliance with Elexes

Navigating Downsizing in the Medical Device Industry: Ensuring Compliance and Operational Continuity with Elexes

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