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QMSR Final Rule Issued by FDA with 2-years Transition Period
News 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
News 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
News 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
News 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FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!
News 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FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!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
News 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!
News 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.
News 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!
News 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
News 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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Recent Posts

  • Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights
  • Navigating Downsizing in the Medical Device Industry: Ensuring Compliance and Operational Continuity with Elexes
  • FAQs – EU Medical Device Regulation (EU MDR 2017/745)
  • Medical Device Testing Requirements: A Complete Guide
  • When is a new 510(k) Submission Required as per the FDA?

Recent Posts

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

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

May 15, 2025
Navigating Downsizing in the Medical Device Industry: Ensuring Compliance and Operational Continuity with Elexes

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

April 24, 2025
FAQs – EU Medical Device Regulation (EU MDR 2017/745)

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

April 16, 2025
Medical Device Testing Requirements: A Complete Guide

Medical Device Testing Requirements: A Complete Guide

April 3, 2025
When is a new 510(k) Submission Required as per the FDA?

When is a new 510(k) Submission Required as per the FDA?

March 19, 2025

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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

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)

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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

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 Requirements: 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

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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?

Outsourcing VP of Regulatory Affairs & Quality Assurance

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