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  • Resource Library: Information for Medical Device Developers

Resource Library: Information for Medical Device Developers

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Guides

Regulation Tool: Europe’s MDR and IVDR

Whitepaper

Effective Preparation and Implementation of Medical Device Quality Management Systems

Whitepaper

Emerging Medical Device Markets in Latin America

Whitepaper

Reducing Medical Device Development Timelines and Creating Value Through Biological Risk Assessments and Chemical Characterization

Publication

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

Guides

NAMSA Standard Terms and Conditions

Guides

NAMSA Web Site Terms of Use

Literature

The NAMSA Brochure

Whitepaper

Risk-Based Monitoring: Exploring the Clinical Site Experience

Literature

MRO Comparison Chart

Literature

Materials Characterization Matrix

Literature

Biocompatibility Matrix

Guides

GLP – GMP Guide

Video

Developing a Biocompatibility Evaluation Plan

Video

Chemical Characteristics of Materials

Literature

Urology InfoSheet

Literature

Regenerative Medicine Cellular Therapy Tissue Engineering InfoSheet

Literature

Physician Training InfoSheet

Literature

Particulate Analysis InfoSheet

Literature

Orthopedic, Spine and Orthobiologics InfoSheet

Literature

Orthobiologic Testing Services InfoSheet

Literature

In Vitro Diagnostics (IVDs) and Companion Diagnostics Info Sheet

Literature

ICH Stability Studies InfoSheet

Literature

Human Anatomic Services InfoSheet

Literature

Gastrointestinal Bariatric InfoSheet

Literature

Extractables / Leachables InfoSheet

Literature

Dermatology and Wound Healing InfoSheet

Literature

Cleaning Studies InfoSheet

Literature

Cardiac, Cardiovascular, Peripheral Vascular and Neurovascular InfoSheet

Literature

Sterility Assurance and Microbiology Services Brochure

Literature

Shelf Life and Package Performance Testing

Literature

Regulatory and Quality Systems Consulting Brochure

Literature

Processing / Reprocessing Validations for Medical Devices Brochure

Literature

Ophthalmic Testing Services Brochure

Literature

Materials Characterization and Analytical Chemistry Brochure

Literature

Efficacy and Functional Studies Brochure

Literature

Clinical Research Brochure

Literature

Cadaveric Testing and Physician Training Brochure

Literature

Biocompatibility Testing Info Sheet

Whitepaper

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

Publication

Current Trends at FDA: Implications for Data Requirements

Whitepaper

China’s New Draft Ordinance on Human Genetic Materials and Its Impact on Clinical Trials

Whitepaper

Planning for Successful Medical Device Reimbursement: So Your Device Is Cleared, Now What?

Whitepaper

The Successful Implant: Ensuring Safety and Performance of Medical Devices

Whitepaper

EU Medical Device Regulatory Framework: Practical Impact of New Regulations

Whitepaper

Developing a European First-in-Human Study: Three Key Decisions

Whitepaper

FDA Regulation of Mobile Medical Apps

Whitepaper

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

Whitepaper

The FDA Refuse to Accept Policy/Acceptance Review Process

Whitepaper

Impact of EN ISO 14971:2012 on Medical Device Risk Assessment in the EU

Whitepaper

The Role of Continuous Physiologic Monitoring in Preclinical Medical Device Studies

Whitepaper

The Medical Device Industry in Korea: Strategies for Market Entry

Whitepaper

Medical Device Development: Thinking Globally, Acting Locally

Whitepaper

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

Whitepaper

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

Whitepaper

Human Factors Testing and Medical Device Reprocessing

Whitepaper

Risk-Based Monitoring: A Cognizant Approach

Whitepaper

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

Whitepaper

FDA Pre-Submission or Q-Sub Program

Whitepaper

Risk-Based Monitoring: Considerations for Clinical Implementation

Publication

Ribonucleotide reductase-mediated

Forms

Shipping Guide – US Customs – French

Forms

Shipping Guide – US Customs – English

Forms

General Sample Submission Form – INTL

Forms

General Sample Submission Form

Forms

Combined GLP Sample Submission Form with Control

Forms

HCTP Sample Submission Form

Forms

GLP Sample Submission Form – With Control Article – INTL

Forms

Combined GLP Sample Submission Form

Publication

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

Forms

Test Article Characterization Definitions

Forms

Test Article Characterization Definitions – Lyon Labs

Publication

BMC Musculoskeletal Disorders

Publication

Biological Safety: More Than Just Test Data

Publication

Assessing the Biological Safety of Polymers

Publication

Using Chemical Characterization to Show Equivalency

Publication

Biological Indicator Characterization

Publication

Making Sure It’s Sterile

Publication

The Challenge to Global Acceptance of Part 3 of ISO 10993

Publication

ISO 10993-6: Tests for Local Effects After Implantation

Publication

The Expanding Role of Contract Research Organizations

Publication

Avoiding Loss of Medical Information During Clinical Investigations

Publication

When To Conduct A Clinical Trial

Publication

The Important Role Of Material And Chemical Characterisation In Device Evaluation

Publication

Outsourcing Testing Services

Publication

Evaluating Pharmaceutical Container Closure Systems

Publication

The Growing Importance of Materials Characterization in Biocompatibility Testing

Publication

Current and Future Issues in Sensitisation Testing

Publication

BIOMATECH NAMSA Testing Laboratory Prevention of bacterial adhesion to medical polymers

Publication

Progress in Testing

Publication

A Practical Guide to ISO 10993-3: Carcinogenicity

Publication

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

Publication

A Practical Guide to ISO 10993-4: Hemocompatibility

Publication

A Practical Guide to ISO 10993-6: Implant Effects

Publication

A Practical Guide to ISO 10993-3: Genotoxicity

Publication

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

Publication

A Practical Guide to ISO 10993-11: Systemic Effects

Publication

A Practical Guide to ISO 10993-10: Irritation

Publication

A Practical Guide to ISO 10993-10: Sensitization

Publication

A Practical Guide to ISO 10993-5: Cytotoxicity

Publication

A Practical Guide to ISO 10993-14: Materials Characterization

Publication

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

Publication

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

Publication

Validating Reusable Medical Devices: An Overview

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