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Why Outsourcing VP of Regulatory and Quality is Essential for Medical Device and IVD Companies Navigating FDA, CE Mark, and Global Compliance
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Why Outsourcing VP of Regulatory and Quality is Essential for Medical Device and IVD Companies Navigating FDA, CE Mark, and Global Compliance

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

FDA Class II medical devices

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Technological Changes that Call for a New 510k Submission
Team Elexes

Technological Changes that Call for a New 510k Submission

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

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

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

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Medical Device Risk Analysis | How often do you review risks at your company? 
Team Elexes

Medical Device Risk Analysis | How often do you review risks at your company? 

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Medical Device Labeling Changes That Require a New 510(k) Submission
Team Elexes

Medical Device Labeling Changes That Require a New 510(k) Submission

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What is Medical Device Labeling, its Components, Types, and Tips to Simplify the Process?
Team Elexes

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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Understanding FDA Recalls for Medical Devices 

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How to Get FDA Approval for Medical Devices?
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How to Get FDA Approval for Medical Devices?

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

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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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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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Most Frequently Asked Questions About EU CE Mark!
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Most Frequently Asked Questions About EU CE Mark!

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Medical Device Import/Export In USA (Regulations for Medical Device Importers & Exporters)
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Medical Device Import/Export In USA (Regulations for Medical Device Importers & Exporters)

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510(k) Clearance | Recommendation Ensuring Minimal Delay!
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510(k) Clearance | Recommendation Ensuring Minimal Delay!

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eCopy Medical Device Submission (How to create a successful eCopy?)
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eCopy Medical Device Submission (How to create a successful eCopy?)

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ISO 9001 | The Complete Guide To Quality Objectives!
Elexes Team

ISO 9001 | The Complete Guide To Quality Objectives!

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Medical Device Design & Development Guide!
Parul Chansoria

Medical Device Design & Development Guide!

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International Standards for design to market for Wearable medical devices!
Elexes Team

International Standards for design to market for Wearable medical devices!

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MDSAP Audit | Complete Guide!
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MDSAP Audit | Complete Guide!

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Importance of regulatory strategy
Elexes Team

Importance of regulatory strategy

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HIPAA Law Violations & Their Serious Consequences
Elexes Team

HIPAA Law Violations & Their Serious Consequences

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Navigating the Regulatory Landscape: Challenges and Opportunities for Medical Device and IVD Startups
Elexes Team

Navigating the Regulatory Landscape: Challenges and Opportunities for Medical Device and IVD Startups

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ANDA or 505(b)(2)?: Choosing the Right Abbreviated Approval Pathway for Your Drug
Elexes Team

ANDA or 505(b)(2)?: Choosing the Right Abbreviated Approval Pathway for Your Drug

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13 Common Mistakes to Avoid in the 510(k) Submission
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13 Common Mistakes to Avoid in the 510(k) Submission

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510K Submission | How To Pass Through FDA’s “Refuse to Accept” Policy!
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510K Submission | How To Pass Through FDA’s “Refuse to Accept” Policy!

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Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
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Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…

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Difference between intended use and indications for use!
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Difference between intended use and indications for use!

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Determining Whether Your Product is a Medical Device! (FDA Medical Device Classification)
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Determining Whether Your Product is a Medical Device! (FDA Medical Device Classification)

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Top 5 Common Mistakes to Avoid in the 510(k) Submission
Elexes Team

Top 5 Common Mistakes to Avoid in the 510(k) Submission

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HIPAA Law Violations Types, Examples & How to Avoid Them
Elexes Team

HIPAA Law Violations Types, Examples & How to Avoid Them

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Staying Ahead of the Game: A Comprehensive Guide in Navigating the EU MDR
Elexes Team

Staying Ahead of the Game: A Comprehensive Guide in Navigating the EU MDR

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MDR Extension: Navigating the Latest Changes in European Medical Device Regulations
Elexes Team

MDR Extension: Navigating the Latest Changes in European Medical Device Regulations

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Canadian Regulations for Medical Device Manufacturers and Importers
Parul Chansoria

Canadian Regulations for Medical Device Manufacturers and Importers

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What is so special about Harmonised Standards for medical devices and IVDs?
Elexes Team

What is so special about Harmonised Standards for medical devices and IVDs?

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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
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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
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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
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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
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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
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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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Elexes Team

Clinical Evaluation Report (CER)

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

3D Medical Imaging | Revolutionizing The Vision of Medicine

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Postmarket Surveillance: An inescapable sound of noise
Elexes Team

Postmarket Surveillance: An inescapable sound of noise

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Access to De Novo Summaries – A treasure for manufacturers
Elexes Team

Access to De Novo Summaries – A treasure for manufacturers

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CLIA Database: A Centralized Database of Clinical Tests & Instruments
Elexes Team

CLIA Database: A Centralized Database of Clinical Tests & Instruments

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De Novo paving the path for Technological Advancements
Elexes Team

De Novo paving the path for Technological Advancements

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The Harmonized ISO 13485 | For Which countries its applicable?
Elexes Team

The Harmonized ISO 13485 | For Which countries its applicable?

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IEC 60601-1 (Electrical Safety Standards) | Know All About It!
Elexes Team

IEC 60601-1 (Electrical Safety Standards) | Know All About It!

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Know It All About FDA Medical Devices Advisory Committee
Elexes Team

Know It All About FDA Medical Devices Advisory Committee

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IMPORT/EXPORT-U.S: Expand your boundaries
Elexes Team

IMPORT/EXPORT-U.S: Expand your boundaries

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Know The Differences For Proactive Planning | From MDD to MDR!
Elexes Team

Know The Differences For Proactive Planning | From MDD to MDR!

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List of Essential Components for Clinical Evaluation Report!
Elexes Team

List of Essential Components for Clinical Evaluation Report!

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Importance of Well Designed DHF Remediation!
Elexes Team

Importance of Well Designed DHF Remediation!

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CER Challenges That Lead To Non-Compliance!
Elexes Team

CER Challenges That Lead To Non-Compliance!

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De Novo – A Propeller for Innovation!
Elexes Team

De Novo – A Propeller for Innovation!

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510(k) Premarket Notification – A Passport for Market Entry
Elexes Team

510(k) Premarket Notification – A Passport for Market Entry

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Can Wearable Devices Compete With Hospital Capital Equipments?
Elexes Team

Can Wearable Devices Compete With Hospital Capital Equipments?

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510(k) Decision making flowchart | Understand the entire process
Elexes Team

510(k) Decision making flowchart | Understand the entire process

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510(k)
Elexes Team

510(k)

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Wearables
Elexes Team

Wearables

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Invasive Devices
Elexes Team

Invasive Devices

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Latest Portfolio

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
submission 510k submission

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

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