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Change is inevitable – The dynamic world of Medical Device Standards and compliance
Elexes Team

Change is inevitable – The dynamic world of Medical Device Standards and compliance

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Refuse to Accept – An important milestone for your device during the FDA review process
Elexes Team

Refuse to Accept – An important milestone for your device during the FDA review process

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Common pitfalls during the CE marking of a Medical Device or IVD
Elexes Team

Common pitfalls during the CE marking of a Medical Device or IVD

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How do IVDs differ from LDTs? Confused? Here’s the key
Elexes Team

How do IVDs differ from LDTs? Confused? Here’s the key

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All you need to know about a Premarket Approval (PMA) Submission — Route to the US Market for Class III medical devices
Elexes Team

All you need to know about a Premarket Approval (PMA) Submission — Route to the US Market for Class III medical devices

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A to Z of a Clinical Evaluation Report
Elexes Team

A to Z of a Clinical Evaluation Report

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EU Classifications and Rules for CE Marking
Elexes Team

EU Classifications and Rules for CE Marking

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The US FDA Medical Device User Fee for the Fiscal Year 2022
Elexes Team

The US FDA Medical Device User Fee for the Fiscal Year 2022

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ISO 15223-1:2021 Medical Device Symbols – An indispensable part of labeling
Elexes Team

ISO 15223-1:2021 Medical Device Symbols – An indispensable part of labeling

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BS EN ISO 13485:2016/A11:2021
Elexes Team

BS EN ISO 13485:2016/A11:2021

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What does CE Marking imply and why is it required?
Elexes Team

What does CE Marking imply and why is it required?

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FDA’s New Requirements: What the MR based Medical Device Manufacturers need to know
Elexes Team

FDA’s New Requirements: What the MR based Medical Device Manufacturers need to know

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ISO 20417:2021 | Information to be supplied by the manufacturer
Amit

ISO 20417:2021 | Information to be supplied by the manufacturer

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The ABC of Clinical Trials for Medical Devices
Keerthana

The ABC of Clinical Trials for Medical Devices

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Safety First – Risk Management Process for medical devices, software and IVD products
Elexes Team

Safety First – Risk Management Process for medical devices, software and IVD products

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Medical device development end to end
Elexes Team

Medical device development end to end

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Frequently Asked Questions About ISO 13485
Elexes Team

Frequently Asked Questions About ISO 13485

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Best regulatory and quality consulting firm for medical devices, IVDs, and software in India and US
Elexes Team

Best regulatory and quality consulting firm for medical devices, IVDs, and software in India and US

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Accelerated pathway to the market – The know-how of Breakthrough Device Designation Request
Elexes Team

Accelerated pathway to the market – The know-how of Breakthrough Device Designation Request

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What the Medical Device Manufacturers need to know about FDA’s UDI requirements?
Elexes Team

What the Medical Device Manufacturers need to know about FDA’s UDI requirements?

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Why and how do Medical Device Manufacturers conduct an Internal Audit?
Elexes Team

Why and how do Medical Device Manufacturers conduct an Internal Audit?

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A Guide to Training Management for Medical Devices
Team Elexes

A Guide to Training Management for Medical Devices

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Predicate Device: What is it and How to Choose the Right One?
Team Elexes

Predicate Device: What is it and How to Choose the Right One?

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The Importance of Conducting Internal Audits in Medical Device Companies
Team Elexes

The Importance of Conducting Internal Audits in Medical Device Companies

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FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours
Elexes Team

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

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Different types of 510k submissions | Special, Abbreviated vs Traditional 510(k)
Elexes Team

Different types of 510k submissions | Special, Abbreviated vs Traditional 510(k)

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The Role of a Regulatory Director & Why the Idea of Fractional Regulatory Affairs Manager is Catching Up?
Elexes Team

The Role of a Regulatory Director & Why the Idea of Fractional Regulatory Affairs Manager is Catching Up?

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Latest Portfolio

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?
medical device training

A Guide to Training Management for Medical Devices
Predicate Device

Predicate Device: What is it and How to Choose the Right One?
Importance of internal audits

The Importance of Conducting Internal Audits in Medical Device Companies

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