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                        * Medical Devices
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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
                                    Team Elexes

                                  Design and Validation of Phantoms for Medical Imaging Devices

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                                  December 22, 2025
                                    Team Elexes

                                  Noise Reduction and Drift Compensation in Electrochemical and Optical Biosensors

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                                  December 12, 2025
                                    Team Elexes

                                  Batteryless Power Transfer in Implantable IoT Devices: Efficiency, Specific Absorption Rate Safety, and IEC 62304 Considerations

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                                  November 27, 2025
                                    Team Elexes

                                  Accelerated Aging vs. Real-Time Aging: Predictive Correlation for Implantable Devices

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                                  November 20, 2025
                                    Team Elexes

                                  Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices

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                                  May 15, 2025
                                    Team Elexes

                                  Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights

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                                  April 24, 2025
                                    Team Elexes

                                  Navigating Downsizing in the Medical Device Industry: Ensuring Compliance and Operational Continuity with Elexes

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                                  April 16, 2025
                                    Team Elexes

                                  FAQs – EU Medical Device Regulation (EU MDR 2017/745)

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                                  April 3, 2025
                                    Team Elexes

                                  Medical Device Testing Requirements: A Complete Guide

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                                  March 19, 2025
                                    Team Elexes

                                  When is a new 510(k) Submission Required as per the FDA?

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                                  February 26, 2025
                                    Team Elexes

                                  What’s New for 510(k) Submissions in 2025? Key Updates and Insights

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                                  February 5, 2025
                                    Team Elexes

                                  Navigating Cybersecurity in Medical Devices: Simplifying Documentation and Compliance

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                                  January 29, 2025
                                    Team Elexes

                                  Cybersecurity Standards and Requirements for Medical Devices

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                                  January 8, 2025
                                    Team Elexes

                                  Prevalent Medical Devices In Physical Therapy, Upcoming Innovations and Regulatory Insights

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                                  December 18, 2024
                                    Team Elexes

                                  Medical Devices CE Marking regulations in 2024. What’s New and What’s Changing?

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                                  December 11, 2024
                                    Team Elexes

                                  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
                                    Team Elexes

                                  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
                                    Team Elexes

                                  Technological Changes that Call for a New 510k Submission

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                                  September 12, 2024
                                    Team Elexes

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

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                                  September 6, 2024
                                    Team Elexes

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

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                                  August 29, 2024
                                    Team Elexes

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

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                                  August 26, 2024
                                    Team Elexes

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

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                                  August 9, 2024
                                    Team Elexes

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

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                                  July 9, 2024
                                    Elexes Team

                                  Understanding FDA Recalls for Medical Devices

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                                  July 5, 2024
                                    Elexes Team

                                  How to Get FDA Approval for Medical Devices?

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                                  July 3, 2024
                                    Team Elexes

                                  A Guide to Training Management for Medical Devices

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                                  June 24, 2024
                                    Team Elexes

                                  Predicate Device: What is it and How to Choose the Right One?

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                                  June 20, 2024
                                    Team Elexes

                                  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
                                    Elexes Team

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

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                                  May 21, 2024
                                    Elexes Team

                                  The Role of a Regulatory Director & Why the Idea of Fractional Regulatory Affairs Manager is Catching Up?

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                                  May 14, 2024
                                    Team Elexes

                                  A Basic Guide to Mock FDA Inspections/Audits

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                                  March 22, 2024
                                    Keerthana

                                  Most Trusted Medical Device Regulatory Consultants in The US (2024 Update)

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                                  February 13, 2024
                                    Parul Chansoria

                                  Most Frequently Asked Questions About EU CE Mark!

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                                  February 13, 2024
                                    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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                                  February 1, 2024
                                    Elexes Team

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

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                                  January 3, 2024
                                    Elexes Team

                                  ISO 9001 | The Complete Guide To Quality Objectives!

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                                  November 22, 2023
                                    Parul Chansoria

                                  Medical Device Design & Development Guide!

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                                  November 13, 2023
                                    Elexes Team

                                  International Standards for design to market for Wearable medical devices!

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                                  October 10, 2023
                                    Elexes Team

                                  MDSAP Audit | Complete Guide!

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                                  September 21, 2023
                                    Elexes Team

                                  Importance of regulatory strategy

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                                  September 11, 2023
                                    Elexes Team

                                  HIPAA Law Violations & Their Serious Consequences

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                                  September 7, 2023
                                    Elexes Team

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

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                                  August 24, 2023
                                    Elexes Team

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

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                                  August 14, 2023
                                    Elexes Team

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

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                                  August 11, 2023
                                    Elexes Team

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

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                                  August 7, 2023
                                    Elexes Team

                                  Intended Use vs Indications for Use – FDA Definitions and Submission Impact

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                                  August 4, 2023
                                    Elexes Team

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

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                                  June 8, 2023
                                    Elexes Team

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

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                                  June 8, 2023
                                    Elexes Team

                                  HIPAA Law Violations Types, Examples & How to Avoid Them

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                                  June 8, 2023
                                    Elexes Team

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

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                                  April 18, 2023
                                    Elexes Team

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

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                                  February 17, 2023
                                    Parul Chansoria

                                  Canadian Regulations for Medical Device Manufacturers and Importers

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                                  February 17, 2023
                                    Elexes Team

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

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                                  February 17, 2023
                                    Elexes Team

                                  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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                                  February 16, 2023
                                    Elexes Team

                                  Common pitfalls during the CE marking of a Medical Device or IVD

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                                  February 16, 2023
                                    Elexes Team

                                  LDTs vs. IVDs: Understanding FDA’s New Guidelines and Their Impact

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                                  December 2, 2022
                                    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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                                  September 30, 2022
                                    Elexes Team

                                  A to Z of a Clinical Evaluation Report

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                                  September 30, 2022
                                    Elexes Team

                                  EU Classifications and Rules for CE Marking

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                                  September 30, 2022
                                    Elexes Team

                                  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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                                  September 30, 2022
                                    Elexes Team

                                  BS EN ISO 13485:2016/A11:2021

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                                  September 30, 2022
                                    Elexes Team

                                  What does CE Marking imply and why is it required?

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                                  September 30, 2022
                                    Elexes Team

                                  FDA’s New Requirements: What the MR based Medical Device Manufacturers need to know

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                                  September 30, 2022
                                    Team Elexes

                                  ISO 20417:2021 | Information to be supplied by the manufacturer

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                                  September 29, 2022
                                    Keerthana

                                  The ABC of Clinical Trials for Medical Devices

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                                  September 29, 2022
                                    Elexes Team

                                  Safety First – Risk Management Process for medical devices, software and IVD products

                                    Read More Post a Comment
                                  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
                                    Elexes Team

                                  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?

                                    Read More Post a Comment
                                  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

                                    Read More Post a Comment
                                  January 12, 2022
                                    Elexes Team

                                  New Classification list for Medical Device

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                                  November 8, 2021
                                    Elexes Team

                                  Clinical Evaluation Report (CER)

                                    Read More Post a Comment
                                  June 22, 2021
                                    Elexes Team

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

                                    Read More Post a Comment
                                  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

                                    Read More Post a Comment
                                  June 3, 2021
                                    Elexes Team

                                  Postmarket Surveillance: An inescapable sound of noise

                                    Read More Post a Comment
                                  June 3, 2021
                                    Elexes Team

                                  Access to De Novo Summaries – A treasure for manufacturers

                                    Read More Post a Comment
                                  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

                                    Read More Post a Comment
                                  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

                                    Read More Post a Comment
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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

                  Design and Validation of Phantoms for Medical Imaging Devices

                  FDA’s ASCA Program: Driving Predictability in Standards-Based Medical Device Testing

                  Noise Reduction and Drift Compensation in Electrochemical and Optical Biosensors

                  FDA Introduces TEMPO Pilot to Accelerate Digital Health for Chronic Diseases

                  Batteryless Power Transfer in Implantable IoT Devices: Efficiency, Specific Absorption Rate Safety, and IEC 62304 Considerations

                  Windows 10 End-of-Support: What Medical Device Manufacturers Must Know

                  TGA Launches EU MDR Transition Web Publication Service: What Manufacturers Need to Know

                  Accelerated Aging vs. Real-Time Aging: Predictive Correlation for Implantable Devices

                  EU Launches Pilot Coordinated Assessment Program for CI/PS: What Medical Device Sponsors Need to Know

                  Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices

                  FDA Issues Revised Pre-RFD Guidance: What Industry Needs to Know

                  FDA Issues Draft Guidance on QMSR Information for Premarket Submissions

                  Notified Bodies Warn Shortage Could Hinder AI Regulation

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