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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
Team Elexes

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FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!
Elexes Team

FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!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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Addressing Duodenoscope contamination – An FDA Initiative
Elexes Team

Addressing Duodenoscope contamination – An FDA Initiative

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17 years Journey – Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (POP)
Elexes Team

17 years Journey – Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (POP)

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Is EU-MDR coming later? EU MDD to MDR – A major change 
Elexes Team

Is EU-MDR coming later? EU MDD to MDR – A major change 

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Breakthroughs in Cardiovascular Treatments – Where Science becomes the Saviour
Elexes Team

Breakthroughs in Cardiovascular Treatments – Where Science becomes the Saviour

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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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Why Outsourcing VP of Regulatory and Quality is Essential for Medical Device and IVD Companies Navigating FDA, CE Mark, and Global Compliance
Team Elexes

Why Outsourcing VP of Regulatory and Quality is Essential for Medical Device and IVD Companies Navigating FDA, CE Mark, and Global Compliance

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Why Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies
Team Elexes

Why Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies

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Latest Portfolio

Navigating Cybersecurity in Medical Devices Simplifying Documentation and Compliance

Navigating Cybersecurity in Medical Devices: Simplifying Documentation and Compliance
Cybersecurity Standards and Requirements for Medical Devices

Cybersecurity Standards and Requirements for Medical Devices
Prevalent Medical Devices In Physical Therapy, Upcoming Innovations and Regulatory Insights 

Prevalent Medical Devices In Physical Therapy, Upcoming Innovations and Regulatory Insights 
Medical Devices CE Marking regulations in 2024

Medical Devices CE Marking regulations in 2024. What’s New and What’s Changing?
VP for Medical Device and IVD companies

Why Outsourcing VP of Regulatory and Quality is Essential for Medical Device and IVD Companies Navigating FDA, CE Mark, and Global Compliance
Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies

Why Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies
FDA II medical devices

FDA Class II medical devices
technological changes that call for new 510(k) submission

Technological Changes that Call for a New 510k Submission
quality management system eQMS

Medical Device Quality Management System | Why Switch to an Electronic QMS?
Post-Market Surveillance For Medical Devices & IVDs

Post-Market Surveillance For Medical Devices & IVDs | Requirements & Data Collection
medical device risk analysis

Medical Device Risk Analysis | How often do you review risks at your company? 
labeling changes that need new 510(k) submission

Medical Device Labeling Changes That Require a New 510(k) Submission
medical device labeling components, types, tips

What is Medical Device Labeling, its Components, Types, and Tips to Simplify the Process?
FDA Recalls

Understanding FDA Recalls for Medical Devices 
FDA approval for medical devices

How to Get FDA Approval for Medical Devices?

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