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Trade Articles

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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 Design Briefs | January 2021

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

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MedTech Insight | October 2020

Requests for Additional Information During EU Audits

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MedTech Intelligence | August 2020

Managing Testing Strategies Under the EU MDR

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Medical Design & Outsourcing | August 2020

Exceeding Regulatory Requirements: Beyond the Checklist 

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Medical Product Outsourcing | July 2019

The OEM’s Roadmap to Navigating MDR

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Medical Product Outsourcing | June 2019

Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR

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Med Device Online | May 2019

Preparing For MDR? Start With A Gap Analysis

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MedTech Intelligence | February 2019

Preparing for MDR: Don’t Forget about Class I Reusable Devices

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Medical Design & Outsourcing | November 2018

Pre-Clinical Medical Device Testing Under ISO 10993-1 and the MDR

 

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Med-Tech Innovation | April 2021

Interpreting ISO Standards to streamline testing and submissions

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Medical Product Outsourcing | April 2021

The Evolution of Chemical Characterization for Medical Devices

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Medical Product Outsourcing | November 2020

Quality Assurance When Supply Chain Disruptions Arise

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Medical Product Outsourcing | September 2020

Facts to Ensure MDR Success 

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Orthopedic Design & Technology | August 2020

Avoiding Contradictions: Testing Advice for Manufacturers 

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Today's Medical Developments | June 2019

Regulations: Preparing for the EU’s MDR

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Medical Design & Outsourcing | May 2019

How Should Medtech Manufacturers Cope With Sterilization Plant Closures?

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Medical Device and Diagnostic Industry | May 2019

Is Your Testing Program Ready for the EU MDRs?

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Medical Design & Outsourcing | April 2019

What you need to know about reusable devices and Europe’s MDR

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Medical Design Briefs | February 2019

Got Your Game Plan? The OEM Playbook to Navigating Pre-Clinical Device Testing Under MDR & ISO 10993-1

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MedTech Intelligence | November 2018

How to Plan for EU MDR So You Can Sleep at Night