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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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Time to revisit your Medical Device’s classification in Australia (TGA): Reclassification Update in Brief
Elexes Team

Time to revisit your Medical Device’s classification in Australia (TGA): Reclassification Update in Brief

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How can a Medical Device Single Audit Program (MDSAP) certification help a Medical Device Manufacturer?
Elexes Team

How can a Medical Device Single Audit Program (MDSAP) certification help a Medical Device Manufacturer?

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ISO 10993-12:2021
Elexes Team

ISO 10993-12:2021

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New Classification list for Medical Device
Elexes Team

New Classification list for Medical Device

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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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A Basic Guide to Mock FDA Inspections/Audits
Team Elexes

A Basic Guide to Mock FDA Inspections/Audits

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8 Common Healthcare Compliance & Regulatory Challenges & Their Solutions
Parul Chansoria

8 Common Healthcare Compliance & Regulatory Challenges & Their Solutions

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Streamlining Healthcare Regulatory Compliance | Everything You Must Know
Keerthana

Streamlining Healthcare Regulatory Compliance | Everything You Must Know

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Most Trusted Medical Device Regulatory Consultants in The US (2024 Update)
Keerthana

Most Trusted Medical Device Regulatory Consultants in The US (2024 Update)

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technological changes that call for new 510(k) submission

Technological Changes that Call for a New 510k Submission
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Medical Device Risk Analysis | How often do you review risks at your company? 
labeling changes that need new 510(k) submission

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What is Medical Device Labeling, its Components, Types, and Tips to Simplify the Process?
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Understanding FDA Recalls for Medical Devices 
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How to Get FDA Approval for Medical Devices?
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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
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FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours
types of 510k

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

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

A Basic Guide to Mock FDA Inspections/Audits

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