Try our Chrome extension
Easily add the current web-page from your browser directly into your changedetection.io tool, more great features coming soon!
Chrome Webstore
Changedetection.io needs your support!
You can help us by supporting changedetection.io on these platforms;
- Rate us at AlternativeTo.net
- Star us on GitHub
- Follow us at Twitter/X
- G2 Software reviews
- Check us out on LinkedIn
- And tell your friends and colleagues :)
The more popular changedetection.io is, the more time we can dedicate to adding amazing features!
Many thanks :)
changedetection.io team
Not yet seconds ago
False
Not yet seconds ago
37 minutes ago
| * Home * Services + Regulatory Submissions o US Regulatory Submissions o EU MDR Consultants o EU IVDR o UK CA o Canadian Regulatory Submissions o TGA regulatory consultants o International Regulatory Services + Medical Devices o SaMD o IVD-LDT o Implants o Wearables o Combination Devices o Companion Diagnostics + Quality System Management (QSR) o MDSAP o ISO 13485 o ISO 15189 o ISO 9001 o Compliance Audits o CAPA + Clinical Evaluation Report (CER) + Post Approval Support + Regulatory and Compliance Training * Testimonials * Resources + Elexes Blog + Updates & Trends + Success Stories + e-Learning o Videos o Infographics * About Us + Our Story + Career Menu * Home * Services + Regulatory Submissions o US Regulatory Submissions o EU MDR Consultants o EU IVDR o UK CA o Canadian Regulatory Submissions o TGA regulatory consultants o International Regulatory Services + Medical Devices o SaMD o IVD-LDT o Implants o Wearables o Combination Devices o Companion Diagnostics + Quality System Management (QSR) o MDSAP o ISO 13485 o ISO 15189 o ISO 9001 o Compliance Audits o CAPA + Clinical Evaluation Report (CER) + Post Approval Support + Regulatory and Compliance Training * Testimonials * Resources + Elexes Blog + Updates & Trends + Success Stories + e-Learning o Videos o Infographics * About Us + Our Story + Career Contact Elexes Blog * Home * Elexes Blog Leave this field empty if you're human: By submitting your information, you agree to receive periodic emails from Elexes. You may unsubscribe from these communications at anytime. Search Search * Medical Devices * SaMD * IVD-LDT * Wearables December 29, 2025 Team Elexes Design and Validation of Phantoms for Medical Imaging Devices Read More Post a Comment December 22, 2025 Team Elexes Noise Reduction and Drift Compensation in Electrochemical and Optical Biosensors Read More Post a Comment December 12, 2025 Team Elexes Batteryless Power Transfer in Implantable IoT Devices: Efficiency, Specific Absorption Rate Safety, and IEC 62304 Considerations Read More Post a Comment November 27, 2025 Team Elexes Accelerated Aging vs. Real-Time Aging: Predictive Correlation for Implantable Devices Read More Post a Comment November 20, 2025 Team Elexes Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices Read More Post a Comment May 15, 2025 Team Elexes Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights Read More Post a Comment April 24, 2025 Team Elexes Navigating Downsizing in the Medical Device Industry: Ensuring Compliance and Operational Continuity with Elexes Read More Post a Comment April 16, 2025 Team Elexes FAQs – EU Medical Device Regulation (EU MDR 2017/745) Read More Post a Comment April 3, 2025 Team Elexes Medical Device Testing Requirements: A Complete Guide Read More Post a Comment March 19, 2025 Team Elexes When is a new 510(k) Submission Required as per the FDA? Read More Post a Comment February 26, 2025 Team Elexes What’s New for 510(k) Submissions in 2025? Key Updates and Insights Read More Post a Comment February 5, 2025 Team Elexes Navigating Cybersecurity in Medical Devices: Simplifying Documentation and Compliance Read More Post a Comment January 29, 2025 Team Elexes Cybersecurity Standards and Requirements for Medical Devices Read More Post a Comment January 8, 2025 Team Elexes Prevalent Medical Devices In Physical Therapy, Upcoming Innovations and Regulatory Insights Read More Post a Comment December 18, 2024 Team Elexes Medical Devices CE Marking regulations in 2024. What’s New and What’s Changing? Read More Post a Comment 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 Read More Post a Comment December 4, 2024 Team Elexes Why Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies Read More Post a Comment October 24, 2024 Elexes Team FDA Class II medical devices Read More Post a Comment October 7, 2024 Team Elexes Technological Changes that Call for a New 510k Submission Read More Comments Off on Technological Changes that Call for a New 510k Submission September 12, 2024 Team Elexes Medical Device Quality Management System | Why Switch to an Electronic QMS? Read More Post a Comment September 6, 2024 Team Elexes Post-Market Surveillance For Medical Devices & IVDs | Requirements & Data Collection Read More Comments Off on Post-Market Surveillance For Medical Devices & IVDs | Requirements & Data Collection August 29, 2024 Team Elexes Medical Device Risk Analysis | How often do you review risks at your company? Read More Post a Comment August 26, 2024 Team Elexes Medical Device Labeling Changes That Require a New 510(k) Submission Read More Post a Comment August 9, 2024 Team Elexes What is Medical Device Labeling, its Components, Types, and Tips to Simplify the Process? Read More Post a Comment July 9, 2024 Elexes Team Understanding FDA Recalls for Medical Devices Read More Post a Comment July 5, 2024 Elexes Team How to Get FDA Approval for Medical Devices? Read More Post a Comment July 3, 2024 Team Elexes A Guide to Training Management for Medical Devices Read More Post a Comment June 24, 2024 Team Elexes Predicate Device: What is it and How to Choose the Right One? Read More Post a Comment June 20, 2024 Team Elexes The Importance of Conducting Internal Audits in Medical Device Companies Read More Post a Comment June 19, 2024 Elexes Team FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours Read More Post a Comment June 17, 2024 Elexes Team Different types of 510(k) submissions | Special 510(k), Abbreviated 510(k) vs Traditional 510(k) Read More Post a Comment May 21, 2024 Elexes Team The Role of a Regulatory Director & Why the Idea of Fractional Regulatory Affairs Manager is Catching Up? Read More Post a Comment May 14, 2024 Team Elexes A Basic Guide to Mock FDA Inspections/Audits Read More Post a Comment March 22, 2024 Keerthana Most Trusted Medical Device Regulatory Consultants in The US (2024 Update) Read More Post a Comment February 13, 2024 Parul Chansoria Most Frequently Asked Questions About EU CE Mark! Read More Post a Comment February 13, 2024 Elexes Team Medical Device Import/Export In USA (Regulations for Medical Device Importers & Exporters) Read More 1 Comment February 2, 2024 Elexes Team 510(k) Clearance | Recommendation Ensuring Minimal Delay! Read More Post a Comment February 1, 2024 Elexes Team eCopy Medical Device Submission (How to create a successful eCopy?) Read More Post a Comment January 3, 2024 Elexes Team ISO 9001 | The Complete Guide To Quality Objectives! Read More Post a Comment November 22, 2023 Parul Chansoria Medical Device Design & Development Guide! Read More Post a Comment November 13, 2023 Elexes Team International Standards for design to market for Wearable medical devices! Read More Post a Comment October 10, 2023 Elexes Team MDSAP Audit | Complete Guide! Read More 1 Comment September 21, 2023 Elexes Team Importance of regulatory strategy Read More Post a Comment September 11, 2023 Elexes Team HIPAA Law Violations & Their Serious Consequences Read More Post a Comment September 7, 2023 Elexes Team Navigating the Regulatory Landscape: Challenges and Opportunities for Medical Device and IVD Startups Read More Post a Comment August 24, 2023 Elexes Team 13 Common Mistakes to Avoid in the 510(k) Submission Read More Post a Comment August 14, 2023 Elexes Team 510K Submission | How To Pass Through FDA’s “Refuse to Accept” Policy! Read More Post a Comment August 11, 2023 Elexes Team Premarket Approvals | PMA Basics, supplements, amendments, QMS & More… Read More Post a Comment August 7, 2023 Elexes Team Intended Use vs Indications for Use – FDA Definitions and Submission Impact Read More Post a Comment August 4, 2023 Elexes Team Determining Whether Your Product is a Medical Device! (FDA Medical Device Classification) Read More Post a Comment June 8, 2023 Elexes Team Top 5 Common Mistakes to Avoid in the 510(k) Submission Read More Post a Comment June 8, 2023 Elexes Team HIPAA Law Violations Types, Examples & How to Avoid Them Read More Post a Comment June 8, 2023 Elexes Team Staying Ahead of the Game: A Comprehensive Guide in Navigating the EU MDR Read More Post a Comment April 18, 2023 Elexes Team MDR Extension: Navigating the Latest Changes in European Medical Device Regulations Read More Post a Comment February 17, 2023 Parul Chansoria Canadian Regulations for Medical Device Manufacturers and Importers Read More Post a Comment February 17, 2023 Elexes Team What is so special about Harmonised Standards for medical devices and IVDs? Read More Post a Comment February 17, 2023 Elexes Team Change is inevitable – The dynamic world of Medical Device Standards and compliance Read More Post a Comment February 16, 2023 Elexes Team Refuse to Accept – An important milestone for your device during the FDA review process Read More Post a Comment February 16, 2023 Elexes Team Common pitfalls during the CE marking of a Medical Device or IVD Read More Post a Comment February 16, 2023 Elexes Team LDTs vs. IVDs: Understanding FDA’s New Guidelines and Their Impact Read More Post a Comment 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 Read More Post a Comment September 30, 2022 Elexes Team A to Z of a Clinical Evaluation Report Read More Post a Comment September 30, 2022 Elexes Team EU Classifications and Rules for CE Marking Read More Post a Comment September 30, 2022 Elexes Team The US FDA Medical Device User Fee for the Fiscal Year 2022 Read More Post a Comment September 30, 2022 Elexes Team ISO 15223-1:2021 Medical Device Symbols – An indispensable part of labeling Read More Post a Comment September 30, 2022 Elexes Team BS EN ISO 13485:2016/A11:2021 Read More Post a Comment September 30, 2022 Elexes Team What does CE Marking imply and why is it required? Read More Post a Comment September 30, 2022 Elexes Team FDA’s New Requirements: What the MR based Medical Device Manufacturers need to know Read More Post a Comment September 30, 2022 Team Elexes ISO 20417:2021 | Information to be supplied by the manufacturer Read More Post a Comment September 29, 2022 Keerthana The ABC of Clinical Trials for Medical Devices Read More Post a Comment 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 Read More Post a Comment September 22, 2022 Elexes Team Frequently Asked Questions About ISO 13485 Read More Post a Comment September 22, 2022 Elexes Team Best regulatory and quality consulting firm for medical devices, IVDs, and software in India and US Read More Post a Comment September 21, 2022 Elexes Team Accelerated pathway to the market – The know-how of Breakthrough Device Designation Request Read More Post a Comment September 21, 2022 Elexes Team What the Medical Device Manufacturers need to know about FDA’s UDI requirements? Read More Post a Comment 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 Read More Post a Comment July 22, 2022 Elexes Team How a Medical Device Single Audit Program (MDSAP) certification help a Medical Device Manufacturer? Read More Post a Comment 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 Read More Post a Comment 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! Read More Post a Comment 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 Read More Post a Comment 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? Read More Post a Comment June 3, 2021 Elexes Team IEC 60601-1 (Electrical Safety Standards) | Know All About It! Read More Post a Comment June 3, 2021 Elexes Team Know It All About FDA Medical Devices Advisory Committee Read More Post a Comment June 3, 2021 Elexes Team IMPORT/EXPORT-U.S: Expand your boundaries Read More Post a Comment June 3, 2021 Elexes Team Know The Differences For Proactive Planning | From MDD to MDR! Read More Post a Comment June 3, 2021 Elexes Team List of Essential Components for Clinical Evaluation Report! Read More Post a Comment June 3, 2021 Elexes Team Importance of Well Designed DHF Remediation! Read More Post a Comment June 3, 2021 Elexes Team CER Challenges That Lead To Non-Compliance! Read More Post a Comment June 3, 2021 Elexes Team De Novo: A Propeller for Innovation in the Medical Device Regulatory Framework Read More Post a Comment June 3, 2021 Elexes Team 510(k) Premarket Notification – A Passport for Market Entry Read More Post a Comment March 17, 2021 Elexes Team Can Wearable Devices Compete With Hospital Capital Equipments? Read More Post a Comment 1 2 Load More Regulatory & Compliance Consultant Looking for a Regulatory & Quality Compliance Consultant? Contact Us Never miss out on any important update on the regulatory & compliance industry across the globe. Subscribe to our newsletter now. Leave this field empty if you're human: Linkedin X-twitter Medium Youtube Facebook Instagram Services * Medical devices * SaMD * LDT/IVD * Blogs * Contact Us * Privacy Policy * Cancellation & Refund Policy * Terms & Conditions Recent News 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 Copyright 2025, Elexes Medical Consulting Pvt. Ltd. All Rights Reserved Working Hours : Monday to Friday 9:00 AM - 7:00 PM +1 408-475-8091 jennifer@elexes.com Contact Book an Appointment Latest Portfolio 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 MHRA Plans Risk-Proportionate AI and Medical Device Oversight Need Any Help? Or Looking For an Agent 9806071234 sendmail@example.com Working Hours : Sun-monday, 09am-5pm © 2024 Elexes. All Rights Reserved. | * Home * Services + Regulatory Submissions o US Regulatory Submissions o EU MDR Consultants o EU IVDR o UK CA o Canadian Regulatory Submissions o TGA regulatory consultants o International Regulatory Services + Medical Devices o SaMD o IVD-LDT o Implants o Wearables o Combination Devices o Companion Diagnostics + Quality System Management (QSR) o MDSAP o ISO 13485 o ISO 15189 o ISO 9001 o Compliance Audits o CAPA + Clinical Evaluation Report (CER) + Post Approval Support + Regulatory and Compliance Training * Testimonials * Resources + Elexes Blog + Updates & Trends + Success Stories + e-Learning o Videos o Infographics * About Us + Our Story + Career Menu * Home * Services + Regulatory Submissions o US Regulatory Submissions o EU MDR Consultants o EU IVDR o UK CA o Canadian Regulatory Submissions o TGA regulatory consultants o International Regulatory Services + Medical Devices o SaMD o IVD-LDT o Implants o Wearables o Combination Devices o Companion Diagnostics + Quality System Management (QSR) o MDSAP o ISO 13485 o ISO 15189 o ISO 9001 o Compliance Audits o CAPA + Clinical Evaluation Report (CER) + Post Approval Support + Regulatory and Compliance Training * Testimonials * Resources + Elexes Blog + Updates & Trends + Success Stories + e-Learning o Videos o Infographics * About Us + Our Story + Career Contact Elexes Blog * Home * Elexes Blog Leave this field empty if you're human: By submitting your information, you agree to receive periodic emails from Elexes. You may unsubscribe from these communications at anytime. Search Search * Medical Devices * SaMD * IVD-LDT * Wearables January 5, 2026 Team Elexes Advances in Microfluidic Channel Surface Modification for Enhanced Bio-compatibility Read More Post a Comment December 29, 2025 Team Elexes Design and Validation of Phantoms for Medical Imaging Devices Read More Post a Comment December 22, 2025 Team Elexes Noise Reduction and Drift Compensation in Electrochemical and Optical Biosensors Read More Post a Comment December 12, 2025 Team Elexes Batteryless Power Transfer in Implantable IoT Devices: Efficiency, Specific Absorption Rate Safety, and IEC 62304 Considerations Read More Post a Comment November 27, 2025 Team Elexes Accelerated Aging vs. Real-Time Aging: Predictive Correlation for Implantable Devices Read More Post a Comment November 20, 2025 Team Elexes Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices Read More Post a Comment May 15, 2025 Team Elexes Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights Read More Post a Comment April 24, 2025 Team Elexes Navigating Downsizing in the Medical Device Industry: Ensuring Compliance and Operational Continuity with Elexes Read More Post a Comment April 16, 2025 Team Elexes FAQs – EU Medical Device Regulation (EU MDR 2017/745) Read More Post a Comment April 3, 2025 Team Elexes Medical Device Testing Requirements: A Complete Guide Read More Post a Comment March 19, 2025 Team Elexes When is a new 510(k) Submission Required as per the FDA? Read More Post a Comment February 26, 2025 Team Elexes What’s New for 510(k) Submissions in 2025? Key Updates and Insights Read More Post a Comment February 5, 2025 Team Elexes Navigating Cybersecurity in Medical Devices: Simplifying Documentation and Compliance Read More Post a Comment January 29, 2025 Team Elexes Cybersecurity Standards and Requirements for Medical Devices Read More Post a Comment January 8, 2025 Team Elexes Prevalent Medical Devices In Physical Therapy, Upcoming Innovations and Regulatory Insights Read More Post a Comment December 18, 2024 Team Elexes Medical Devices CE Marking regulations in 2024. What’s New and What’s Changing? Read More Post a Comment 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 Read More Post a Comment December 4, 2024 Team Elexes Why Outsourcing Regulatory and Quality Department has become The Key to Success for Medical Device Companies Read More Post a Comment October 24, 2024 Elexes Team FDA Class II medical devices Read More Post a Comment October 7, 2024 Team Elexes Technological Changes that Call for a New 510k Submission Read More Comments Off on Technological Changes that Call for a New 510k Submission September 12, 2024 Team Elexes Medical Device Quality Management System | Why Switch to an Electronic QMS? Read More Post a Comment September 6, 2024 Team Elexes Post-Market Surveillance For Medical Devices & IVDs | Requirements & Data Collection Read More Comments Off on Post-Market Surveillance For Medical Devices & IVDs | Requirements & Data Collection August 29, 2024 Team Elexes Medical Device Risk Analysis | How often do you review risks at your company? Read More Post a Comment August 26, 2024 Team Elexes Medical Device Labeling Changes That Require a New 510(k) Submission Read More Post a Comment August 9, 2024 Team Elexes What is Medical Device Labeling, its Components, Types, and Tips to Simplify the Process? Read More Post a Comment July 9, 2024 Elexes Team Understanding FDA Recalls for Medical Devices Read More Post a Comment July 5, 2024 Elexes Team How to Get FDA Approval for Medical Devices? Read More Post a Comment July 3, 2024 Team Elexes A Guide to Training Management for Medical Devices Read More Post a Comment June 24, 2024 Team Elexes Predicate Device: What is it and How to Choose the Right One? Read More Post a Comment June 20, 2024 Team Elexes The Importance of Conducting Internal Audits in Medical Device Companies Read More Post a Comment June 19, 2024 Elexes Team FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours Read More Post a Comment June 17, 2024 Elexes Team Different types of 510(k) submissions | Special 510(k), Abbreviated 510(k) vs Traditional 510(k) Read More Post a Comment May 21, 2024 Elexes Team The Role of a Regulatory Director & Why the Idea of Fractional Regulatory Affairs Manager is Catching Up? Read More Post a Comment May 14, 2024 Team Elexes A Basic Guide to Mock FDA Inspections/Audits Read More Post a Comment March 22, 2024 Keerthana Most Trusted Medical Device Regulatory Consultants in The US (2024 Update) Read More Post a Comment February 13, 2024 Parul Chansoria Most Frequently Asked Questions About EU CE Mark! Read More Post a Comment February 13, 2024 Elexes Team Medical Device Import/Export In USA (Regulations for Medical Device Importers & Exporters) Read More 1 Comment February 2, 2024 Elexes Team 510(k) Clearance | Recommendation Ensuring Minimal Delay! Read More Post a Comment February 1, 2024 Elexes Team eCopy Medical Device Submission (How to create a successful eCopy?) Read More Post a Comment January 3, 2024 Elexes Team ISO 9001 | The Complete Guide To Quality Objectives! Read More Post a Comment November 22, 2023 Parul Chansoria Medical Device Design & Development Guide! Read More Post a Comment November 13, 2023 Elexes Team International Standards for design to market for Wearable medical devices! Read More Post a Comment October 10, 2023 Elexes Team MDSAP Audit | Complete Guide! Read More 1 Comment September 21, 2023 Elexes Team Importance of regulatory strategy Read More Post a Comment September 11, 2023 Elexes Team HIPAA Law Violations & Their Serious Consequences Read More Post a Comment September 7, 2023 Elexes Team Navigating the Regulatory Landscape: Challenges and Opportunities for Medical Device and IVD Startups Read More Post a Comment August 24, 2023 Elexes Team 13 Common Mistakes to Avoid in the 510(k) Submission Read More Post a Comment August 14, 2023 Elexes Team 510K Submission | How To Pass Through FDA’s “Refuse to Accept” Policy! Read More Post a Comment August 11, 2023 Elexes Team Premarket Approvals | PMA Basics, supplements, amendments, QMS & More… Read More Post a Comment August 7, 2023 Elexes Team Intended Use vs Indications for Use – FDA Definitions and Submission Impact Read More Post a Comment August 4, 2023 Elexes Team Determining Whether Your Product is a Medical Device! (FDA Medical Device Classification) Read More Post a Comment June 8, 2023 Elexes Team Top 5 Common Mistakes to Avoid in the 510(k) Submission Read More Post a Comment June 8, 2023 Elexes Team HIPAA Law Violations Types, Examples & How to Avoid Them Read More Post a Comment June 8, 2023 Elexes Team Staying Ahead of the Game: A Comprehensive Guide in Navigating the EU MDR Read More Post a Comment April 18, 2023 Elexes Team MDR Extension: Navigating the Latest Changes in European Medical Device Regulations Read More Post a Comment February 17, 2023 Parul Chansoria Canadian Regulations for Medical Device Manufacturers and Importers Read More Post a Comment February 17, 2023 Elexes Team What is so special about Harmonised Standards for medical devices and IVDs? Read More Post a Comment February 17, 2023 Elexes Team Change is inevitable – The dynamic world of Medical Device Standards and compliance Read More Post a Comment February 16, 2023 Elexes Team Refuse to Accept – An important milestone for your device during the FDA review process Read More Post a Comment February 16, 2023 Elexes Team Common pitfalls during the CE marking of a Medical Device or IVD Read More Post a Comment February 16, 2023 Elexes Team LDTs vs. IVDs: Understanding FDA’s New Guidelines and Their Impact Read More Post a Comment 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 Read More Post a Comment September 30, 2022 Elexes Team A to Z of a Clinical Evaluation Report Read More Post a Comment September 30, 2022 Elexes Team EU Classifications and Rules for CE Marking Read More Post a Comment September 30, 2022 Elexes Team The US FDA Medical Device User Fee for the Fiscal Year 2022 Read More Post a Comment September 30, 2022 Elexes Team ISO 15223-1:2021 Medical Device Symbols – An indispensable part of labeling Read More Post a Comment September 30, 2022 Elexes Team BS EN ISO 13485:2016/A11:2021 Read More Post a Comment September 30, 2022 Elexes Team What does CE Marking imply and why is it required? Read More Post a Comment September 30, 2022 Elexes Team FDA’s New Requirements: What the MR based Medical Device Manufacturers need to know Read More Post a Comment September 30, 2022 Team Elexes ISO 20417:2021 | Information to be supplied by the manufacturer Read More Post a Comment September 29, 2022 Keerthana The ABC of Clinical Trials for Medical Devices Read More Post a Comment 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 Read More Post a Comment September 22, 2022 Elexes Team Frequently Asked Questions About ISO 13485 Read More Post a Comment September 22, 2022 Elexes Team Best regulatory and quality consulting firm for medical devices, IVDs, and software in India and US Read More Post a Comment September 21, 2022 Elexes Team Accelerated pathway to the market – The know-how of Breakthrough Device Designation Request Read More Post a Comment September 21, 2022 Elexes Team What the Medical Device Manufacturers need to know about FDA’s UDI requirements? Read More Post a Comment 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 Read More Post a Comment July 22, 2022 Elexes Team How a Medical Device Single Audit Program (MDSAP) certification help a Medical Device Manufacturer? Read More Post a Comment 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 Read More Post a Comment 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! Read More Post a Comment 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 Read More Post a Comment 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? Read More Post a Comment June 3, 2021 Elexes Team IEC 60601-1 (Electrical Safety Standards) | Know All About It! Read More Post a Comment June 3, 2021 Elexes Team Know It All About FDA Medical Devices Advisory Committee Read More Post a Comment June 3, 2021 Elexes Team IMPORT/EXPORT-U.S: Expand your boundaries Read More Post a Comment June 3, 2021 Elexes Team Know The Differences For Proactive Planning | From MDD to MDR! Read More Post a Comment June 3, 2021 Elexes Team List of Essential Components for Clinical Evaluation Report! Read More Post a Comment June 3, 2021 Elexes Team Importance of Well Designed DHF Remediation! Read More Post a Comment June 3, 2021 Elexes Team CER Challenges That Lead To Non-Compliance! Read More Post a Comment June 3, 2021 Elexes Team De Novo: A Propeller for Innovation in the Medical Device Regulatory Framework Read More Post a Comment June 3, 2021 Elexes Team 510(k) Premarket Notification – A Passport for Market Entry Read More Post a Comment 1 2 Load More Regulatory & Compliance Consultant Looking for a Regulatory & Quality Compliance Consultant? Contact Us Never miss out on any important update on the regulatory & compliance industry across the globe. Subscribe to our newsletter now. Leave this field empty if you're human: Linkedin X-twitter Medium Youtube Facebook Instagram Services * Medical devices * SaMD * LDT/IVD * Blogs * Contact Us * Privacy Policy * Cancellation & Refund Policy * Terms & Conditions Recent News 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 Copyright 2025, Elexes Medical Consulting Pvt. Ltd. All Rights Reserved Working Hours : Monday to Friday 9:00 AM - 7:00 PM +1 408-475-8091 jennifer@elexes.com Contact Book an Appointment Latest Portfolio 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 Need Any Help? Or Looking For an Agent 9806071234 sendmail@example.com Working Hours : Sun-monday, 09am-5pm © 2024 Elexes. All Rights Reserved. |
For now, Differences are performed on text, not graphically, only the latest screenshot is available.
Screenshot requires Playwright/WebDriver enabled