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Comprehensive Guidance On Reusable Medical Device Processing Requirements: Cleaning, Disinfection and Sterilization Validations

Preclinical Considerations: Testing Regulated Wound Healing Devices

NAMSA Corporate Capabilities

Ex Vivo and In Vitro Tissue Models: Applications Supporting an Early Indication of Therapeutic Outcome

ISO 10993-17 2023 Update: What You Need to Know

Infectious Disease Diagnostic Devices: The Move to at Home Testing and Treatment (Panel Discussion)

The Chemical Characterization Puzzle: Is There a Solution?

When Innovation Outpaces Standardization – Solutions to Support Novel Wound Care Product Development

Biofilm Basics and Beyond

The FDA’s Draft Guidance on AI- and ML-Enabled Device Software Functions

Telling Your Medical Device’s Story to Regulatory Agencies

Clinical Trial Site Budgeting – Risk Mitigation or Budget Control?

A Practical Guide to Writing Summaries of Safety and Clinical Performance

Navigating Trends and Best Practices for Cardiovascular Device Development

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

The Relationship Between Risk Management and Labeling

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

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

Optimizing Preclinical Testing for Cardiovascular Medical Devices

Biostatistics in IVD Clinical Research – Decoding the Biostatistical Black Box

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

Chemical Characterization Best Practices: Assumptions of TTC and Exhaustive Extraction

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

In Vitro Testing Strategies for Microbial Barrier Effectiveness

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

ISO 14155:2020 – What Every Clinical Professional Should Know

The Basics of IVDR Clinical Studies

NAMSA Lab Equipment and Facilities

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

NAMSA Brochure Japanese

Clinical Challenges under the EU MDR

NAMSA Brochure

NAMSA Histology Laboratory

Pathology Assessment Of Medical Devices: Understanding the Basics

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

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

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

Analysis of Medical Claims Data for Economic Summaries and Alternative Uses

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

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

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

IVDD to IVDR: How to Successfully Make the Transition

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 APEX Program™ 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

Emerging Medical Device Markets in Latin America

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

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