Resource Library: Information for Medical Device Developers

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

In Vitro Diagnostic Regulation (IVDR) Readiness Guide

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

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

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

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

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

Regulatory Consulting Info Sheet

Quality Systems Info Sheet

Processing / Reprocessing for Medical Devices Info Sheet

Material Characterization and Analytical Chemistry Info Sheet

Data Management / EDC Info Sheet

Clinical Study Management Data Safety Info Sheet

Clinical & Statistical Info Sheet

Biostatistics & Study Design Info Sheet

Biological Safety Evaluation Info Sheet

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

Leveraging Post-Market Surveillance and Post-Market Clinical Follow-Up Data to Support EU Medical Device Regulation (MDR) Compliance

NAMSA Product Development Strategy Brochure

Regulation Tool: European Union’s MDR and IVDR

Effective Preparation and 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 and Creating Value Through Biological Risk Assessments and Chemical Characterization

Europe’s Emerging Medical Device Regulations and Their Impact on Packaging Decisions

The NAMSA Brochure

Risk-Based Monitoring: Exploring the Clinical Site Experience

MRO Comparison Chart

Materials Characterization Matrix

Biocompatibility Matrix

GLP – GMP Guide

Dec 2013 : China Regulatory & Industry Monthly

Nov 2013 : China Regulatory & Industry Monthly

Oct 2013 : China Regulatory & Industry Monthly

Sep 2013 : China Regulatory & Industry Monthly

Aug 2013 : China Regulatory & Industry Monthly

Jul 2013 : China Regulatory & Industry Monthly

Jun 2013 : China Regulatory & Industry Monthly

May 2013 : China Regulatory & Industry Monthly

Apr 2013 : China Regulatory & Industry Monthly

Mar 2013 : China Regulatory & Industry Monthly

Feb 2013 : China Regulatory & Industry Monthly

Jan 2013 : China Regulatory & Industry Monthly

Developing a Biocompatibility Evaluation Plan

Chemical Characteristics of Materials

Urology InfoSheet

Regenerative Medicine Cellular Therapy Tissue Engineering InfoSheet

Physician Training InfoSheet

Particulate Analysis InfoSheet

Orthopedic, Spine and Orthobiologics InfoSheet

Orthobiologic Testing Services InfoSheet

In Vitro Diagnostic (IVD) Info Sheet

Cleaning Studies Info Sheet

Human Anatomic Services InfoSheet

Gastrointestinal Bariatric InfoSheet

Dermatology and Wound Healing InfoSheet

Cardiac, Cardiovascular, Peripheral Vascular and Neurovascular InfoSheet

Sterility Assurance and Microbiology Services Brochure

Shelf Life and Package Performance Testing

Ophthalmic Testing Services Brochure

Efficacy and Functional Studies Brochure

Cadaveric Testing and Physician Training Brochure

Biocompatibility Testing Info Sheet

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

Current Trends at FDA: Implications for Data Requirements

New Legislation in Israel for Medical Device Registration and the Role of the Israeli Registration Holder (IRH)

The Medical Device Industry in Korea: Strategies for Market Entry

Medical Device Development: Thinking Globally, Acting Locally

MedTech Outsourcing: Is the Past Any Indication of the Future?

The Sunshine Act: What Manufacturers, Clinical Professionals, and Researchers Need to Know

Risk-Based Monitoring: A Cognizant Approach

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

Real Challenges. Real Solutions.

Risk-Based Monitoring: Considerations for Clinical Implementation

Dec 2012 : China Regulatory & Industry Monthly

Ribonucleotide reductase-mediated

Finding a Faster Path

Shipping Guide – US Customs – French

Shipping Guide – US Customs – English

General Sample Submission Form

Combined GLP Sample Submission Form with Control

HCTP Sample Submission Form

Combined GLP Sample Submission Form

Strategies for registering and testing medical devices under China’s new rules

Test Article Characterization Definitions

Test Article Characterization Definitions – Lyon Labs

BMC Musculoskeletal Disorders

Biological Safety: More Than Just Test Data

Assessing the Biological Safety of Polymers

Using Chemical Characterization to Show Equivalency

Biological Indicator Characterization

Making Sure It’s Sterile

The Challenge to Global Acceptance of Part 3 of ISO 10993

ISO 10993-6: Tests for Local Effects After Implantation

The Expanding Role of Contract Research Organizations

Avoiding Loss of Medical Information During Clinical Investigations

When To Conduct A Clinical Trial

The Important Role Of Material And Chemical Characterisation In Device Evaluation

Outsourcing Testing Services

Evaluating Pharmaceutical Container Closure Systems

The Growing Importance of Materials Characterization in Biocompatibility Testing

Current and Future Issues in Sensitisation Testing

BIOMATECH NAMSA Testing Laboratory Prevention of bacterial adhesion to medical polymers

Progress in Testing

A Practical Guide to ISO 10993-3: Carcinogenicity

A Practical Guide to ISO 10993-12: Sample Preparation and Reference Materials

A Practical Guide to ISO 10993-4: Hemocompatibility

A Practical Guide to ISO 10993-6: Implant Effects

A Practical Guide to ISO 10993-3: Genotoxicity

A Practical Guide to ISO 10993-11: Designing Subchronic and Chronic Systemic Toxicity Tests

A Practical Guide to ISO 10993-11: Systemic Effects

A Practical Guide to ISO 10993-10: Irritation

A Practical Guide to ISO 10993-10: Sensitization

A Practical Guide to ISO 10993-5: Cytotoxicity

A Practical Guide to ISO 10993-14: Materials Characterization

A Practical Guide to ISO 10993: Part 1 – Introduction to the Standards

Satisfying Medical Device Biocompatibility Requirements: What’s a Supplier to Do?

Validating Reusable Medical Devices: An Overview