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January 5, 2026
Team Elexes
Advances in Microfluidic Channel Surface Modification for Enhanced Bio-compatibility
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December 29, 2025
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Design and Validation of Phantoms for Medical Imaging Devices
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Noise Reduction and Drift Compensation in Electrochemical and Optical Biosensors
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Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights
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Medical Device Testing Requirements: A Complete Guide
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March 19, 2025
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When is a new 510(k) Submission Required as per the FDA?
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What’s New for 510(k) Submissions in 2025? Key Updates and Insights
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Cybersecurity Standards and Requirements for Medical Devices
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Prevalent Medical Devices In Physical Therapy, Upcoming Innovations and Regulatory Insights
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December 18, 2024
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Medical Devices CE Marking regulations in 2024. What’s New and What’s Changing?
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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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December 4, 2024
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Why Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies
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October 24, 2024
Elexes Team
FDA Class II medical devices
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October 7, 2024
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Technological Changes that Call for a New 510k Submission
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September 12, 2024
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Medical Device Quality Management System | Why Switch to an Electronic QMS?
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September 6, 2024
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Post-Market Surveillance For Medical Devices & IVDs | Requirements & Data Collection
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August 29, 2024
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Medical Device Risk Analysis | How often do you review risks at your company?
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August 26, 2024
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Medical Device Labeling Changes That Require a New 510(k) Submission
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August 9, 2024
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What is Medical Device Labeling, its Components, Types, and Tips to Simplify the Process?
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July 9, 2024
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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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A Guide to Training Management for Medical Devices
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Predicate Device: What is it and How to Choose the Right One?
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June 20, 2024
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The Importance of Conducting Internal Audits in Medical Device Companies
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June 19, 2024
Elexes Team
FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours
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June 17, 2024
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Different types of 510(k) submissions | Special 510(k), Abbreviated 510(k) 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?
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A Basic Guide to Mock FDA Inspections/Audits
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March 22, 2024
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February 13, 2024
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Most Frequently Asked Questions About EU CE Mark!
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Elexes Team
Medical Device Import/Export In USA (Regulations for Medical Device Importers & Exporters)
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February 2, 2024
Elexes Team
510(k) Clearance | Recommendation Ensuring Minimal Delay!
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Elexes Team
eCopy Medical Device Submission (How to create a successful eCopy?)
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ISO 9001 | The Complete Guide To Quality Objectives!
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November 22, 2023
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Medical Device Design & Development Guide!
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International Standards for design to market for Wearable medical devices!
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MDSAP Audit | Complete Guide!
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September 21, 2023
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Importance of regulatory strategy
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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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Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
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Intended Use vs Indications for Use – FDA Definitions and Submission Impact
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Determining Whether Your Product is a Medical Device! (FDA Medical Device Classification)
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June 8, 2023
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Top 5 Common Mistakes to Avoid in the 510(k) Submission
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June 8, 2023
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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
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April 18, 2023
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MDR Extension: Navigating the Latest Changes in European Medical Device Regulations
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February 17, 2023
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Canadian Regulations for Medical Device Manufacturers and Importers
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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
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February 16, 2023
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
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LDTs vs. IVDs: Understanding FDA’s New Guidelines and Their Impact
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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
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A to Z of a Clinical Evaluation Report
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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
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September 30, 2022
Elexes Team
ISO 15223-1:2021 Medical Device Symbols – An indispensable part of labeling
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Elexes Team
BS EN ISO 13485:2016/A11:2021
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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
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ISO 20417:2021 | Information to be supplied by the manufacturer
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Elexes Team
Safety First – Risk Management Process for medical devices, software and IVD products
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September 22, 2022
Elexes Team
Medical device development end to end
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September 22, 2022
Elexes Team
Frequently Asked Questions About ISO 13485
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September 22, 2022
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Best regulatory and quality consulting firm for medical devices, IVDs, and software in India and US
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September 21, 2022
Elexes Team
Accelerated pathway to the market – The know-how of Breakthrough Device Designation Request
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September 21, 2022
Elexes Team
What the Medical Device Manufacturers need to know about FDA’s UDI requirements?
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September 21, 2022
Elexes Team
Why and how do Medical Device Manufacturers conduct an Internal Audit?
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July 22, 2022
Elexes Team
Time to revisit your Medical Device’s classification in Australia (TGA): Reclassification Update in Brief
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July 22, 2022
Elexes Team
How a Medical Device Single Audit Program (MDSAP) certification help a Medical Device Manufacturer?
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January 12, 2022
Elexes Team
ISO 10993-12:2021
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January 12, 2022
Elexes Team
New Classification list for Medical Device
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November 8, 2021
Elexes Team
Clinical Evaluation Report (CER)
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June 22, 2021
Elexes Team
Modernization of 510(k) – A major milestone to safer and better healthcare
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June 15, 2021
Elexes Team
Is your medical device 510(k) exempt? Understanding the classification of medical devices!
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June 15, 2021
Elexes Team
3D Medical Imaging | Revolutionizing The Vision of Medicine
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June 3, 2021
Elexes Team
Postmarket Surveillance: An inescapable sound of noise
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June 3, 2021
Elexes Team
Access to De Novo Summaries – A treasure for manufacturers
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June 3, 2021
Elexes Team
CLIA Database: A Centralized Database of Clinical Tests & Instruments
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June 3, 2021
Elexes Team
De Novo paving the path for Technological Advancements
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June 3, 2021
Elexes Team
The Harmonized ISO 13485 | For Which countries its applicable?
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June 3, 2021
Elexes Team
IEC 60601-1 (Electrical Safety Standards) | Know All About It!
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June 3, 2021
Elexes Team
Know It All About FDA Medical Devices Advisory Committee
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June 3, 2021
Elexes Team
IMPORT/EXPORT-U.S: Expand your boundaries
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June 3, 2021
Elexes Team
Know The Differences For Proactive Planning | From MDD to MDR!
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June 3, 2021
Elexes Team
List of Essential Components for Clinical Evaluation Report!
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June 3, 2021
Elexes Team
Importance of Well Designed DHF Remediation!
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June 3, 2021
Elexes Team
CER Challenges That Lead To Non-Compliance!
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June 3, 2021
Elexes Team
De Novo: A Propeller for Innovation in the Medical Device Regulatory Framework
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June 3, 2021
Elexes Team
510(k) Premarket Notification – A Passport for Market Entry
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Advances in Microfluidic Channel Surface Modification for Enhanced Bio-compatibility
FDA Eliminates a Major Barrier to Using Real-World Evidence in Drug and Device Reviews
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Noise Reduction and Drift Compensation in Electrochemical and Optical Biosensors
FDA Introduces TEMPO Pilot to Accelerate Digital Health for Chronic Diseases
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Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices
FDA Issues Revised Pre-RFD Guidance: What Industry Needs to Know
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