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Software Precertification Program: An Innovative Approach to Expedite Patient Access for SaMD
Elexes Team

Software Precertification Program: An Innovative Approach to Expedite Patient Access for SaMD

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Are Breast Implants Safe?
Elexes Team

Are Breast Implants Safe?

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Is EU-MDR coming later?
Elexes Team

Is EU-MDR coming later?

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Know the differences for proactive planning – MDD to MDR
Elexes Team

Know the differences for proactive planning – MDD to MDR

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THE A-Z OF CLINICAL EVALUATION REPORT
Elexes Team

THE A-Z OF CLINICAL EVALUATION REPORT

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Make yourself aware of the importance of keeping all design documents tucked in!
Elexes Team

Make yourself aware of the importance of keeping all design documents tucked in!

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Comprehensive CER – A key component to CE Marking
Elexes Team

Comprehensive CER – A key component to CE Marking

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Software as Medical Device (SaMD)
Elexes Team

Software as Medical Device (SaMD)

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Quality Objectives – Driving Improvements
Elexes Team

Quality Objectives – Driving Improvements

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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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Breakthroughs in Cardiovascular Treatments – Where Science becomes the Saviour
Elexes Team

Breakthroughs in Cardiovascular Treatments – Where Science becomes the Saviour

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Vivek Goyal
Elexes Team

Vivek Goyal

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Are you making the right claims on your cosmetic products?
Elexes Team

Are you making the right claims on your cosmetic products?

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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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5 tips for a successful 510(k) submission
Elexes Team

5 tips for a successful 510(k) submission

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eCopy
Elexes Team

eCopy

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510(k) flowchart
Elexes Team

510(k) flowchart

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510(k)
Elexes Team

510(k)

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Wearables
Elexes Team

Wearables

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Active devices
Elexes Team

Active devices

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Elexes Team

Quality Management System

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Elexes Team

Steps involved in setting up a QMS

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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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Overcoming hurdles of launching an IVD in the European market
Elexes Team

Overcoming hurdles of launching an IVD in the European market

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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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10 tips to make your next Grant Application a success!
Elexes Team

10 tips to make your next Grant Application a success!

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Latest Portfolio

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

A Final Guidances On Device Shortage Reporting & Computational Modeling Published By FDA
Three New International Medical Device Software Security Standards Issued By FDA

Three New International Medical Device Software Security Standards Issued By FDA
Medical Device Design & Development Guide!

Medical Device Design & Development Guide!
International Standards for design to market for Wearable medical devices!

International Standards for design to market for Wearable medical devices!
CPSR for cosmetics what is this report and how do you get it

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

What is GMP & Why it is important?
What are GMP Audits, its purpose and how to be prepared for them?

What are GMP Audits, its purpose and how to be prepared for them?
What is Cosmetic PIF & Key Components to be included in it?

What is Cosmetic PIF & Key Components to be included in it?
FDA Applications for Drugs and Biologics

5 Common FDA Applications for Drugs & Biologics
MDSAP Audit | Complete Guide!

MDSAP Audit | Complete Guide!

Women is the future of medtech innovations

Importance of regulatory strategy

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

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

What is Telemedicine & its benefits & approval

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