Resource Library: Information for Medical Device Developers

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

NAMSA Standard Terms and Conditions

NAMSA Web Site Terms of Use

The NAMSA Brochure

Risk-Based Monitoring: Exploring the Clinical Site Experience

MRO Comparison Chart

Materials Characterization Matrix

Biocompatibility Matrix

GLP – GMP Guide

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 Diagnostics (IVDs) and Companion Diagnostics Info Sheet

ICH Stability Studies InfoSheet

Human Anatomic Services InfoSheet

Gastrointestinal Bariatric InfoSheet

Extractables / Leachables InfoSheet

Dermatology and Wound Healing InfoSheet

Cleaning Studies InfoSheet

Cardiac, Cardiovascular, Peripheral Vascular and Neurovascular InfoSheet

Sterility Assurance and Microbiology Services Brochure

Shelf Life and Package Performance Testing

Regulatory and Quality Systems Consulting Brochure

Processing / Reprocessing Validations for Medical Devices Brochure

Ophthalmic Testing Services Brochure

Materials Characterization and Analytical Chemistry Brochure

Efficacy and Functional Studies Brochure

Clinical Research 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

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

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

The Successful Implant: Ensuring Safety and Performance of Medical Devices

EU Medical Device Regulatory Framework: Practical Impact of New Regulations

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

FDA Regulation of Mobile Medical Apps

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

The FDA Refuse to Accept Policy/Acceptance Review Process

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

The Role of Continuous Physiologic Monitoring in Preclinical Medical Device Studies

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

Human Factors Testing and Medical Device Reprocessing

Risk-Based Monitoring: A Cognizant Approach

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

FDA Pre-Submission or Q-Sub Program

Risk-Based Monitoring: Considerations for Clinical Implementation

Ribonucleotide reductase-mediated

Shipping Guide – US Customs – French

Shipping Guide – US Customs – English

General Sample Submission Form – INTL

General Sample Submission Form

Combined GLP Sample Submission Form with Control

HCTP Sample Submission Form

GLP Sample Submission Form – With Control Article – INTL

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