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QMSR Final Rule Issued by FDA with 2-years Transition Period
February 6, 2024
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
January 19, 2024
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
November 30, 2023
Team Elexes

Three New International Medical Device Software Security Standards Issued By FDA

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Women is the future of medtech innovations
September 29, 2023
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FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!
September 18, 2023
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FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!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
August 3, 2023
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!
July 31, 2023
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.
July 27, 2023
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!
March 1, 2023
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
September 30, 2022
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
June 15, 2021
Elexes Team

3D Medical Imaging | Revolutionizing The Vision of Medicine

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Addressing Duodenoscope contamination – An FDA Initiative
June 3, 2021
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)
June 3, 2021
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 
June 3, 2021
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
April 25, 2021
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
May 15, 2025
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
April 24, 2025
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)
April 16, 2025
Team Elexes

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

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Medical Device Testing: A Complete Guide
April 3, 2025
Team Elexes

Medical Device Testing: A Complete Guide

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When is a new 510(k) Submission Required as per the FDA?
March 19, 2025
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
February 26, 2025
Team Elexes

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

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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

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AI and regulatory trends shaping the future of inflammation imaging in healthcare

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