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Resource Library

Access the resources you require for  accelerated medical device development & Commercialization outcomes

Guide
NAMSA Guide: The Design of Clinical Trials for CLIA-Waived Point-of-Care Tests
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Webinar
Reimbursement Opportunities and Challenges in 2020: Factors for Success – A NAMSA and Kalms Consulting sponsored Q&A Panel Discussion
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Webinar
Ensuring your Post-Market Surveillance Process Meets the New ISO 14971:2019 Guidance and MDR/IVDR Requirements
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Webinar
Considerations for Clinical Study Start-Up in a Virtual Environment
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White Paper
Navigating Clinical Trials in the Era of COVID-19: An Assessment of Short-Term and Long-Term Strategies
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Webinar
Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies
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Webinar
Transitioning from EUA to 510(k) Clearance for IVD Products: What to Expect
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Webinar
IVD Clinical Trials: Effective Site Selection Techniques – A Site and CRO Perspective
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Webinar
EU MDR Part 2: How to Approach Clinical Evidence Requirements with Clinical Management & Biostatistics
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Publication
PharmaTech Outlook: Advancing Global Patient Healthcare through Full Continuum CRO Services for Medical Device Sponsors
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Guide
NAMSA Guide: How to Design & Develop EDC Systems for Optimal IVD Clinical Trial Management
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Literature
NAMSA Start-Up 360: Accelerating IVD Product Development
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Webinar
How to Manage Clinical Study Data During the COVID-19 Pandemic
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Webinar
EU MDR Part 1: Current Opportunities & Challenges with Clinical Data-A NAMSA Panel Discussion
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Webinar
Do’s & Don’ts for Early-Stage IVD Product Development & Risk Mitigation
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Webinar
Optimizing Electronic Data Capture (EDC) for IVD Clinical Trials
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Webinar
The COVID-19 Pandemic: Proper Clinical Study Management & Protecting Data Validity
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White Paper
Risk Management Systems: Implications of ISO 14971, ISO/TR 24971 & EU MDR Updates
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Webinar
The Value of Biostatistics: Bringing a New Medical Device to Market
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Webinar
4 Pillars of IVDR: Integrating Post-Market Surveillance, Risk Management, QMS & Performance Evaluation
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Webinar
The New ISO 10993-18:2020 – 10 Things Manufacturers Need to Know Today
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Webinar
Software as a Medical Device (SAMD): Qualifications & Regulatory Requirements
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Case Study
Virtual Vascular Company Partners with NAMSA to Accelerate 510(k) Clearance by 30 Percent
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Webinar
The Biological Evaluation Plan: How can a Step-Wise Approach Create Resource Efficiencies?
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White Paper
Human Factors: Global Considerations & Regulatory Requirements
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Webinar
How to Successfully Launch IVD Products in China
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Webinar
Impacts of the Updated ISO 14971 & Harmonization of MDR/FDA Rules on Risk Management
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White Paper
Medical Device Biological Evaluation Reports: Relevance to ISO 10993-Part 1: 2018
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Webinar
Biostatistics in IVD Clinical Research: What can Make or Break your Product’s Commcercialization?
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Webinar
MDR 10.4.1: What Should we Really be Doing to be Prepared?
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Guide
NAMSA Guide: In Vitro Diagnostic (IVDR) Readiness Guide
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Webinar
How to Implement an Effective Internal Audit Program
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White Paper
CMDE Draft Guidelines’ Impact on In Vitro Diagnostic Clinical Trials & Reagents
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Webinar
How to Select the Right EU Notified Body for IVDR Compliance
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White Paper
How to Select the Proper EU Notified Body for your Medical Device Organization
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Webinar
Use of OUS Clinical Data in Medical Device Product Development
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Webinar
Design Control: Understanding the Benefits of Starting Early & Why Its Necessary
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Webinar
Understanding Medical Device Reimbursement Fundamentals to Achieve Commercial Success
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Literature
Clinical Research Services Brochure
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White Paper
Particulates in Preclinical Testing: Understanding the Impact on Overall Device Biological Safety
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White Paper
Medical Device Reimbursement Strategy: How to Plan for Successful Market Commercialization
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Webinar
Understanding & Applying ISO 19227 Requirements for Orthopedics Manufacturers
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Publication
Medical Device Landscape Report: Trends and Challenges in Clinical Research Outsourcing
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Webinar
IVD Clinical Trials: Essential Components for Product Launch in 2019 & Beyond
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Webinar
EU MDR: General Safety & Performance Requirements for the Biocompatibility of Medical Devices
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Webinar
THE New ISO 10993-1: 2018 – What Now?
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Webinar
EU MDR 2017/745: Optimizing CERs within the Medical Device Lifecycle
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Webinar
How to Effectively Navigate Radiation Sterilization Validation Scenarios
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Webinar
Global Regulatory Requirements for Chemical Characterization: How to Cost-Effectively Demonstrate Biological Safety
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White Paper
Leveraging Post-Market Surveillance & Post-Market Clinical Follow-Up Data to Support EU MDR Compliance
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Webinar
The Effective Design & Development of Preclinical Studies
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Webinar
CFDA Acceptance of Overseas Clinical Trial Data: Understanding the Impact to Medical Device Manufacturers
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Webinar
ISO 10993-1: Understanding the Use & Value of Biocompatibility Safety Evaluation & Risk Assessment Standards for Medical Devices
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Guide
NAMSA Guide: EU MDR & IVDR Regulation Tool
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Webinar
Leveraging Post-Market Surveillance & Clinical Follow-Up Data to Support EU MDR Compliance
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Case Study
NAMSA’s MRO® Approach Expedites 510(k) Clearance for Solvay Dental 360™, Delivers 12 Months & $7.5M in Development Savings
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Webinar
How to Use Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
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White Paper
Effective Preparation & Implementation of Medical Device Quality Management Systems
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Case Study
NAMSA’s MRO® Approach Accelerates PMA Submission Timeline by 23 Months for Global Biosurgical Firm
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White Paper
Emerging Medical Device Markets in Latin America
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White Paper
Reducing Medical Device Development Timelines & Creating Value through Biological Risk Assessments & Chemical Characterization
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Literature
NAMSA Brochure
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White Paper
Risk-Based Monitoring: Exploring the Clinical Site Experience
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Literature
Biocompatibility Matrix
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White Paper
Risk-Based Monitoring: Considerations for Clinical Implementation
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White Paper
Risk-Based Monitoring: Setting up the Structure for a Systematic Approach
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White Paper
Risk-Based Monitoring: A Cognizant Approach
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White Paper
Joining Preclinical and Clinical Development: A Practical Approach to Reducing Medical Device Timelines
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