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Archives: Resources

The FDA’s Draft Guidance on AI- and ML-Enabled Device Software Functions

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Telling Your Medical Device’s Story to Regulatory Agencies

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Clinical Trial Site Budgeting – Risk Mitigation or Budget Control?

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A Practical Guide to Writing Summaries of Safety and Clinical Performance

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Navigating Trends and Best Practices for Cardiovascular Device Development

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MedTech Chats: MEGA BIOPHARMA Partners with NAMSA to De-Risk Disruptive Dental Technology

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The Relationship Between Risk Management and Labeling

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Exhaustive Extractions in E&L Studies – Endpoint Determination Challenges, Expectations and Reality

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Navigating the Landscape for Over-the-Counter or Direct-to-Consumer IVD Tests

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Optimizing Preclinical Testing for Cardiovascular Medical Devices

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Biostatistics in IVD Clinical Research – Decoding the Biostatistical Black Box

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Expanding your Market: Submitting U.S. EUA COVID-19 Products for EU IVDR Compliance

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Chemical Characterization Best Practices: Assumptions of TTC and Exhaustive Extraction

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FDA QMSR: What do the Proposed Changes Mean for Industry?

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In Vitro Testing Strategies for Microbial Barrier Effectiveness

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FDA and NAMSA Present: Reducing Regulatory Burden and Streamlining FDA Review through ASCA Pilot Program Utilization

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ISO 14155:2020 – What Every Clinical Professional Should Know

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The Basics of IVDR Clinical Studies

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NAMSA Lab Equipment and Facilities

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Transitioning from EUA to 510(k) for IVD Products: Planning to Execution

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NAMSA Brochure Japanese

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Clinical Challenges under the EU MDR

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NAMSA Brochure

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NAMSA Histology Laboratory

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Pathology Assessment Of Medical Devices: Understanding the Basics

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ASCA Accreditation for Biocompatiblity Testing: What’s it All About?

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NAMSA Preclinical Research: Recommendations for the Evaluation of Investigational Heart Valve Technologies

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The EU In Vitro Diagnostic Regulation (IVDR): Clarification Regarding Commonly Asked Questions

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Analysis of Medical Claims Data for Economic Summaries and Alternative Uses

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The Critical Role of Biostatistics in Streamlining the Preclinical to Clinical Pathway

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Alternative Test Methods for Medical Device Sterilization Validation: An Industry Panel Discussion

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SaMD Product Development: Addressing Challenges through Early Integration of Regulatory, Quality and Clinical Data Strategies

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Key Factors for Successful Clinical Study Database Design and Data Management

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MDR Clinical Evaluation Reports: Key Elements and Lessons Learned for Successful Compliance

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ISO 10993-23:2021 Tests For Irritation – What Manufacturers Must Understand Today

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IVDD to IVDR: How to Successfully Make the Transition

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IVDR Implementation: First Steps for Compliance for Products Already on the European Market

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EUDAMED Actor Registration Module: A Step Towards Greater Medical Device and IVD Product Safety and Transparency

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Achieving EU and U.S. Commercialization Success: The Critical Linkage Between Reimbursement and Regulatory Strategies

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Strategies for Selecting the Right In Vivo Models for Regulated Preclinical Studies

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NAMSA Guide: The Design of Clinical Trials for CLIA-Waived Point-of-Care Tests

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Reimbursement Opportunities and Challenges : Factors for Success – A NAMSA and Kalms Consulting sponsored Q&A Panel Discussion

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Ensuring your Post-Market Surveillance Process Meets the New ISO 14971:2019 Guidance and MDR/IVDR Requirements

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Considerations for Clinical Study Start-Up in a Virtual Environment

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Navigating Clinical Trials in the Era of COVID-19: An Assessment of Short-Term and Long-Term Strategies

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Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies

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Transitioning from EUA to 510(k) Clearance for IVD Products: What to Expect

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IVD Clinical Trials: Effective Site Selection Techniques – A Site and CRO Perspective

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EU MDR Part 2: How to Approach Clinical Evidence Requirements with Clinical Management & Biostatistics

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PharmaTech Outlook: Advancing Global Patient Healthcare through Full Continuum CRO Services for Medical Device Sponsors

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NAMSA Guide: How to Design & Develop EDC Systems for Optimal IVD Clinical Trial Management

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NAMSA Start-Up 360: Accelerating IVD Product Development

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How to Manage Clinical Study Data During the COVID-19 Pandemic

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EU MDR Part 1: Current Opportunities & Challenges with Clinical Data-A NAMSA Panel Discussion

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Do’s & Don’ts for Early-Stage IVD Product Development & Risk Mitigation

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Optimizing Electronic Data Capture (EDC) for IVD Clinical Trials

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The COVID-19 Pandemic: Proper Clinical Study Management & Protecting Data Validity

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Risk Management Systems: Implications of ISO 14971, ISO/TR 24971 & EU MDR Updates

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The Value of Biostatistics: Bringing a New Medical Device to Market

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4 Pillars of IVDR: Integrating Post-Market Surveillance, Risk Management, QMS & Performance Evaluation

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The New ISO 10993-18:2020 – 10 Things Manufacturers Need to Know Today

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Software as a Medical Device (SAMD): Qualifications & Regulatory Requirements

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Virtual Vascular Company Partners with NAMSA to Accelerate 510(k) Clearance by 30 Percent

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The Biological Evaluation Plan: How can a Step-Wise Approach Create Resource Efficiencies?

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Human Factors: Global Considerations & Regulatory Requirements

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How to Successfully Launch IVD Products in China

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Impacts of the Updated ISO 14971 & Harmonization of MDR/FDA Rules on Risk Management

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Medical Device Biological Evaluation Reports: Relevance to ISO 10993-Part 1: 2018

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Biostatistics in IVD Clinical Research: What can Make or Break your Product’s Commcercialization?

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MDR 10.4.1: What Should we Really be Doing to be Prepared?

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NAMSA Guide: In Vitro Diagnostic (IVDR) Readiness Guide

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How to Implement an Effective Internal Audit Program

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CMDE Draft Guidelines’ Impact on In Vitro Diagnostic Clinical Trials & Reagents

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How to Select the Right EU Notified Body for IVDR Compliance

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How to Select the Proper EU Notified Body for your Medical Device Organization

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Use of OUS Clinical Data in Medical Device Product Development

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Design Control: Understanding the Benefits of Starting Early & Why Its Necessary

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Understanding Medical Device Reimbursement Fundamentals to Achieve Commercial Success

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Clinical Research Services Brochure

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Particulates in Preclinical Testing: Understanding the Impact on Overall Device Biological Safety

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Medical Device Reimbursement Strategy: How to Plan for Successful Market Commercialization

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Understanding & Applying ISO 19227 Requirements for Orthopedics Manufacturers

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Medical Device Landscape Report: Trends and Challenges in Clinical Research Outsourcing

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IVD Clinical Trials: Essential Components for Product Launch in 2019 & Beyond

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EU MDR: General Safety & Performance Requirements for the Biocompatibility of Medical Devices

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THE New ISO 10993-1: 2018 – What Now?

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EU MDR 2017/745: Optimizing CERs within the Medical Device Lifecycle

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How to Effectively Navigate Radiation Sterilization Validation Scenarios

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Global Regulatory Requirements for Chemical Characterization: How to Cost-Effectively Demonstrate Biological Safety

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Leveraging Post-Market Surveillance & Post-Market Clinical Follow-Up Data to Support EU MDR Compliance

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The Effective Design & Development of Preclinical Studies

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CFDA Acceptance of Overseas Clinical Trial Data: Understanding the Impact to Medical Device Manufacturers

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ISO 10993-1: Understanding the Use & Value of Biocompatibility Safety Evaluation & Risk Assessment Standards for Medical Devices

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NAMSA Guide: EU MDR & IVDR Regulation Tool

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Leveraging Post-Market Surveillance & Clinical Follow-Up Data to Support EU MDR Compliance

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NAMSA APEX Program™ Expedites 510(k) Clearance for Solvay Dental 360™, Delivers 12 Months & $7.5M in Development Savings

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How to Use Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

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Effective Preparation & Implementation of Medical Device Quality Management Systems

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Emerging Medical Device Markets in Latin America

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Reducing Medical Device Development Timelines & Creating Value through Biological Risk Assessments & Chemical Characterization

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Risk-Based Monitoring: Exploring the Clinical Site Experience

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Biocompatibility Matrix

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GLP & GMP Guide

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Risk-Based Monitoring: Considerations for Clinical Implementation

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Risk-Based Monitoring: Setting up the Structure for a Systematic Approach

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Risk-Based Monitoring: A Cognizant Approach

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Joining Preclinical and Clinical Development: A Practical Approach to Reducing Medical Device Timelines

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