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Trade Articles

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Medical Product Outsourcing | July 2023

New Proposed Changes to the Standard for Toxicological Risk Assessment

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MedTech Intelligence | June 2023

The MDR Deadline Extension: Use the Time Wisely

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Medical Products Outsourcing | October 2022

Following the Test Article: Timelines, Expectations for E/L Testing

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Medical Products Outsourcing | September 2022

The Rising Bar for Extractables/Leachables Testing

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MedTech Intelligence | July 2022

State-of-the-Art: Unpacking MDR’s Evolving Requirements

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Medical Product Outsourcing | June 2022

The Advantages of Bioburden Screening for Sterilization Validation

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Orthopedic Design & Technology | May 2022

The Problem Plaguing U.S. Antimicrobial Joint Implant Development

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Medical Plastics News | December 2021

ISO 10993-18:2020’s new challenges for manufacturers submitting in the EU

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Medical Product Outsourcing | December 2021

Prepare Now for Updated ISO 10993-17

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Medical Design Briefs | November 2021

Creating Robust Reprocessing Instructions for Reusable Device IFUs

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MedTech Intelligence | October 2021

Addressing ‘Equivocal’ Toxicological Assessment Results with Risk Mitigation Strategies

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Orthopedic Design & Technology | September 2021

Disinfectant Efficacy Testing: How Limiting Bioburden Keeps You Compliant

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Medical Plastics News | July 2021

Prepare to Meet Thy Regulator

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Medical Product Outsourcing | June 2021

Packaging Design Considerations to Ensure a Safe, Sterile Medical Device

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Medical Product Outsourcing | April 2021

The Evolution of Chemical Characterization for Medical Devices

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Med-Tech Innovation News | March 2021

Interpreting ISO Standards to streamline testing and submissions

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Medical Design Briefs | January 2021

New Regulations, New Timelines: How Chemistry Changed in Response to ISO 10993-18:2020

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Medical Design and Outsourcing | June 2023

5 critical questions medical device manufacturers must ask potential lab testing partners

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Medical Products Outsourcing | November 2022

Addressing Myths About Extractables/Leachables Testing of Medical Devices

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Medical Plastics News | September 2022

Extracting the truth: the importance of complete chemical characterization

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Medical Product Outsourcing | July 2022

The Complex Regulatory Pathway for Medical Devices and Drug Delivery Systems

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MedTech Intelligence | June 2022

Release Kinetics: An Important Element in Understanding Toxicological Risk of Chemical Constituents

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Medical Product Outsourcing | March 2022

U.S. Premarket Submissions: Understanding the Necessary Regulatory Controls

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Today's Medical Developments | December 2021

Evaluating risks associated with medical device chemicals: Medical devices with biological risk assessments as current as 2020 could be outdated with anticipated updates to ISO 10993-17

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Medical Products Outsourcing | November 2021

Recent ISO Standards Highlight Global Submission Complexities

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MedTech Intelligence | September 2021

Modalities, Timelines & Tips: What Manufacturers Need to Know About Tissue Sterilization Validation

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Medical Design & Outsourcing | August 2021

3 questions medical device manufacturers should ask before ISO 10993-17 updates

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Medical Product Outsourcing | July 2021

Guidance on Skin Irritation With a Push to Achieve the 3 Rs

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Orthopedic Design & Technology | May 2021

Nitinol and FDA Guidance: Key Insights to Consider for Medical Devices

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Medical Device and Diagnostic Industry | April 2021

Understanding Regulatory Expectations for Combination Products

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Medical Product Outsourcing | February 2021

How to Better Prepare for Regulatory Requests and Minimize Impact