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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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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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