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

Key Factors for Successful Clinical Study Database Design and Data Management

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

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

How to Successfully Transition from IVDD to IVDR: A Roadmap of Priorities and Compliance Strategies

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

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

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

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

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

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

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

Considerations for Clinical Study Start-Up in a Virtual Environment

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

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

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

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

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

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

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

NAMSA Start-Up 360: Accelerating IVD Product Development

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

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

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

Optimizing Electronic Data Capture (EDC) for IVD Clinical Trials

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

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

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

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

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

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

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

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

Human Factors: Global Considerations & Regulatory Requirements

How to Successfully Launch IVD Products in China

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

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

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

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

NAMSA Guide: In Vitro Diagnostic (IVDR) Readiness Guide

How to Implement an Effective Internal Audit Program

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

How to Select the Right EU Notified Body for IVDR Compliance

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

Use of OUS Clinical Data in Medical Device Product Development

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

Understanding Medical Device Reimbursement Fundamentals to Achieve Commercial Success

Clinical Research Services Brochure

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

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

Understanding & Applying ISO 19227 Requirements for Orthopedics Manufacturers

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

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

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

THE New ISO 10993-1: 2018 – What Now?

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

How to Effectively Navigate Radiation Sterilization Validation Scenarios

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

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

The Effective Design & Development of Preclinical Studies

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

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

NAMSA Guide: EU MDR & IVDR Regulation Tool

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

NAMSA’s MRO® Approach Expedites 510(k) Clearance for Solvay Dental 360™, Delivers 12 Months & $7.5M in Development Savings

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

Effective Preparation & Implementation of Medical Device Quality Management Systems

NAMSA’s MRO® Approach Accelerates PMA Submission Timeline by 23 Months for Global Biosurgical Firm

Emerging Medical Device Markets in Latin America

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

NAMSA Brochure

Risk-Based Monitoring: Exploring the Clinical Site Experience

Biocompatibility Matrix

GLP & GMP Guide

Risk-Based Monitoring: Considerations for Clinical Implementation

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

Risk-Based Monitoring: A Cognizant Approach

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