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

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
Vaishali

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 
Elexes Team

Understanding FDA Recalls for Medical Devices 

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How to Get FDA Approval for Medical Devices?
Elexes Team

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?
Vaishali

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
Vaishali

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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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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Everything to know about JCI Accreditation | Overview, Benefits, How to get one?
Parul Chansoria

Everything to know about JCI Accreditation | Overview, Benefits, How to get one?

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CE Marking Strategy For Medical Devices | (EU CE Mark)
Elexes Team

CE Marking Strategy For Medical Devices | (EU CE Mark)

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Do’s and Don’ts in a Quality Audit
Parul Chansoria

Do’s and Don’ts in a Quality Audit

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Most Frequently Asked Questions About EU CE Mark!
Parul Chansoria

Most Frequently Asked Questions About EU CE Mark!

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Most Frequently Asked Questions About FDA 510(k) Submission
Amit

Most Frequently Asked Questions About FDA 510(k) Submission

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

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

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QMSR Final Rule Issued by FDA with 2-years Transition Period
Elexes Team

QMSR Final Rule Issued by FDA with 2-years Transition Period

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10 tips to make your next Grant Application a success!
Amit

10 tips to make your next Grant Application a success!

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

510(k) Clearance | Recommendation Ensuring Minimal Delay!

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

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

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HSA Announces Regulatory Fee Revision For Health Products Applicable from 1 July 2024
Elexes Team

HSA Announces Regulatory Fee Revision For Health Products Applicable from 1 July 2024

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FDA Issues First Mass Drug Imports To States From Canada
Elexes Team

FDA Issues First Mass Drug Imports To States From Canada

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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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Regulatory Outsourcing | The Two Staff Augmentation Models For Pharma Companies
Elexes Team

Regulatory Outsourcing | The Two Staff Augmentation Models For Pharma Companies

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Device & Biologics Combination products | Understanding the regulations around it!
Elexes Team

Device & Biologics Combination products | Understanding the regulations around it!

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Three New International Medical Device Software Security Standards Issued By FDA
Team Elexes

Three New International Medical Device Software Security Standards Issued By FDA

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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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CPSR for cosmetics: what is this report and how do you get it?
Elexes Team

CPSR for cosmetics: what is this report and how do you get it?

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What is GMP & Why it is important?
Elexes Team

What is GMP & Why it is important?

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What are GMP Audits, its purpose and how to be prepared for them?
Elexes Team

What are GMP Audits, its purpose and how to be prepared for them?

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What is Cosmetic PIF & Key Components to be included in it?
Elexes Team

What is Cosmetic PIF & Key Components to be included in it?

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5 Common FDA Applications for Drugs & Biologics
Elexes Team

5 Common FDA Applications for Drugs & Biologics

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MDSAP Audit | Complete Guide!
Elexes Team

MDSAP Audit | Complete Guide!

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Women is the future of medtech innovations
Elexes Team

Women is the future of medtech innovations

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Importance of regulatory strategy
Elexes Team

Importance of regulatory strategy

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FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!
Elexes Team

FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!

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Whether your product is cosmetic, a drug, or both? Learn the primary difference! (USA)
Elexes Team

Whether your product is cosmetic, a drug, or both? Learn the primary difference! (USA)

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What is Telemedicine & its benefits & approval
Elexes Team

What is Telemedicine & its benefits & approval

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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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Pros and cons of hiring a medical device consultant
Elexes Team

Pros and cons of hiring a medical device consultant

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A pharmaceutical manufacturing compliance checklist for US companies
Elexes Team

A pharmaceutical manufacturing compliance checklist for US companies

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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
Elexes Team

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

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A Complete Guide to Hiring a Medical device consultant!
Elexes Team

A Complete Guide to Hiring a Medical device consultant!

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Cosmetic labeling requirements USA
Elexes Team

Cosmetic labeling requirements USA

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

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

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

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

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Difference between intended use and indications for use!
Elexes Team

Difference between intended use and indications for use!

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

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

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A Final Guidances On Device Shortage Reporting & Computational Modeling Published By FDA
Team Elexes

A Final Guidances On Device Shortage Reporting & Computational Modeling Published By FDA

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The Top 10 Challenges Faced By Medical Device Manufacturers!
Elexes Team

The Top 10 Challenges Faced By Medical Device Manufacturers!

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Abbreviated New Drug Application (ANDA): What it is, How it Works?
Elexes Team

Abbreviated New Drug Application (ANDA): What it is, How it Works?

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Extension to EU MDR transition period finalized!
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.
Elexes Team

Opill, an Over-The-Counter (OTC) drug was approved by the US F.D.A.

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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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Know Your Food: Understanding the Facts About Food Additives
Elexes Team

Know Your Food: Understanding the Facts About Food Additives

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How well do you know about the ingredients in your cosmetics?
Elexes Team

How well do you know about the ingredients in your cosmetics?

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Companion Diagnostics (CDx): The future of safe and effective therapies!
Elexes Team

Companion Diagnostics (CDx): The future of safe and effective therapies!

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Importing Cosmetic into the US? This is what you need to know!
Elexes Team

Importing Cosmetic into the US? This is what you need to know!

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How are Dietary Supplements regulated in the US?
Elexes Team

How are Dietary Supplements regulated in the US?

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Grant Process – All you need to know!
Elexes Team

Grant Process – All you need to know!

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Biologics, their Unique Characteristics, Applicable Requirements and Regulations
Elexes Team

Biologics, their Unique Characteristics, Applicable Requirements and Regulations

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DDx for effective diagnosis and the regulatory repercussions
Elexes Team

DDx for effective diagnosis and the regulatory repercussions

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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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ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation
Elexes Team

ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation

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BS EN ISO 13485:2016/A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes
Elexes Team

BS EN ISO 13485:2016/A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes

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Change to a Device – How could I be so naive?
Elexes Team

Change to a Device – How could I be so naive?

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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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Quality — The key to customer satisfaction
Elexes Team

Quality — The key to customer satisfaction

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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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Parul Chansoria
Elexes Team

Parul Chansoria

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Mark Harman
Elexes Team

Mark Harman

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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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Is your product Misbranded?
Elexes Team

Is your product Misbranded?

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Ways to Report Medical Device Incidents in Australia via the MDIR System
Elexes Team

Ways to Report Medical Device Incidents in Australia via the MDIR System

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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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Health Canada’s Regulatory requirements for UV light-emitting products with claims pertaining to Covid -19
Elexes Team

Health Canada’s Regulatory requirements for UV light-emitting products with claims pertaining to Covid -19

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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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types of 510k

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