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Resource Library

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

Webinar
AI/ML and SaMD Medical Devices: New and Unique Challenges in Getting to Market
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Wound Care Laboratory Testing Requirements: Your Path to Compliance
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Webinar
Post-Market Clinical Follow-up in Action: A Practical Approach to EU MDR Compliance
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White Paper
Outsource Your Way to Operational Excellence
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The Impact of Shifting Site of Care on Clinical Research: A Vascular Office-Based Laboratory Approach
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Clinical Data Requirements Under MDR: A Panel Discussion
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White Paper
Navigating Dual Regulations: Strategies for IVD Market Approval in China and the EU
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Webinar
Considerations for Navigating ISO 22442-3 Viral Inactivation Studies
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Comprehensive Guidance On Reusable Medical Device Processing Requirements: Cleaning, Disinfection and Sterilization Validations
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Preclinical Considerations: Testing Regulated Wound Healing Devices
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Video
NAMSA Corporate Capabilities
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Ex Vivo and In Vitro Tissue Models: Applications Supporting an Early Indication of Therapeutic Outcome
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Webinar
ISO 10993-17 2023 Update: What You Need to Know
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Infectious Disease Diagnostic Devices: The Move to at Home Testing and Treatment (Panel Discussion)
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The Chemical Characterization Puzzle: Is There a Solution?
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When Innovation Outpaces Standardization – Solutions to Support Novel Wound Care Product Development
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Biofilm Basics and Beyond
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White Paper
The FDA’s Draft Guidance on AI- and ML-Enabled Device Software Functions
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Webinar
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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Webinar
A Practical Guide to Writing Summaries of Safety and Clinical Performance
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Case Study
MedTech Chats: MEGA BIOPHARMA Partners with NAMSA to De-Risk Disruptive Dental Technology
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White Paper
The Relationship Between Risk Management and Labeling
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Webinar
Exhaustive Extractions in E&L Studies – Endpoint Determination Challenges, Expectations and Reality
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Webinar
Chemical Characterization Best Practices: Assumptions of TTC and Exhaustive Extraction
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Webinar
FDA and NAMSA Present: Reducing Regulatory Burden and Streamlining FDA Review through ASCA Pilot Program Utilization
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Video
NAMSA Lab Equipment and Facilities
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Literature
NAMSA Brochure Japanese
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Literature
NAMSA Brochure
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Video
NAMSA Histology Laboratory
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Webinar
ASCA Accreditation for Biocompatiblity Testing: What’s it All About?
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Literature
NAMSA Start-Up 360: Accelerating IVD Product Development
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Case Study
Virtual Vascular Company Partners with NAMSA to Accelerate 510(k) Clearance by 30 Percent
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White Paper
Medical Device Biological Evaluation Reports: Relevance to ISO 10993-Part 1: 2018
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Literature
Clinical Research Services Brochure
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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Guide
NAMSA Guide: EU MDR & IVDR Regulation Tool
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Case Study
NAMSA APEX PROGRAM Expedites 510(k) Clearance for Solvay Dental 360™, Delivers 12 Months & $7.5M in Development Savings
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Literature
Biocompatibility Matrix
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Literature
GLP & GMP Guide
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