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FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!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FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!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

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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Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights
Team Elexes

Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights

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

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

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FAQs – EU Medical Device Regulation (EU MDR 2017/745)
Team Elexes

FAQs – EU Medical Device Regulation (EU MDR 2017/745)

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Medical Device Testing: A Complete Guide
Team Elexes

Medical Device Testing: A Complete Guide

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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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Latest Portfolio

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
FAQs on EU Medical Device Regulation

FAQs – EU Medical Device Regulation (EU MDR 2017/745)
Comprehensive guide to medical device testing for safety and regulatory compliance

Medical Device Testing: A Complete Guide
When is a new 510(k) Submission Required as per the FDA

When is a new 510(k) Submission Required as per the FDA?
510(k) Submissions in 2025: Key Updates and Insights

What’s New for 510(k) Submissions in 2025? Key Updates and Insights
Navigating FDA Cybersecurity in Medical Devices Simplifying Documentation and Compliance

Navigating Cybersecurity in Medical Devices: Simplifying Documentation and Compliance
FDA Cybersecurity Medical Devices & Standards

Cybersecurity Standards and Requirements for Medical Devices
Physical therapy devices, 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 teams for medical device success with Elexes

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

FDA Class II medical devices
New Technology in Medical Devices | 510(k) Submission

Technological Changes that Call for a New 510k Submission
Electronic QMS for Medical Device Compliance

Medical Device Quality Management System | Why Switch to an Electronic QMS?

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