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Year: 2021
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  • 2021
Clinical Evaluation Report (CER)
Medical Devices November 8, 2021
Elexes Team

Clinical Evaluation Report (CER)

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Modernization of 510(k) – A major milestone to safer and better healthcare
Medical Devices June 22, 2021
Elexes Team

Modernization of 510(k) – A major milestone to safer and better healthcare

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Is your medical device 510(k) exempt? Understanding the classification of medical devices!
Medical Devices June 15, 2021
Elexes Team

Is your medical device 510(k) exempt? Understanding the classification of medical devices!

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3D Medical Imaging | Revolutionizing The Vision of Medicine
Medical Devices June 15, 2021
Elexes Team

3D Medical Imaging | Revolutionizing The Vision of Medicine

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Expert's Desk June 15, 2021
Elexes Team

Are you designing to meet your customer needs?

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Expert's Desk June 15, 2021
Elexes Team

Safety Concerns of Raw Milk Cheese

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Expert's Desk June 15, 2021
Elexes Team

Funding Trends – Medical Device Industry

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Postmarket Surveillance: An inescapable sound of noise
Medical Devices June 3, 2021
Elexes Team

Postmarket Surveillance: An inescapable sound of noise

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Expert's Desk June 3, 2021
Elexes Team

Product Development

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Addressing Duodenoscope contamination – An FDA Initiative
News June 3, 2021
Elexes Team

Addressing Duodenoscope contamination – An FDA Initiative

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Recent Posts

  • 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: A Complete Guide
  • When is a new 510(k) Submission Required as per the FDA?
  • What’s New for 510(k) Submissions in 2025? Key Updates and Insights

Recent Posts

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: A Complete Guide

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

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

February 26, 2025

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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

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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?

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

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

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 teams for medical device success with Elexes

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

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FDA Class II medical devices

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Technological Changes that Call for a New 510k Submission

Why switch to an electronic quality management system -eQMS

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

post-market-surveillance for medical devices & IVSs

Post-Market Surveillance For Medical Devices & IVDs | Requirements & Data Collection

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