+1 (888) 794-0077

Trade Articles

MedTech Insight | October 2020

Requests for Additional Information During EU Audits

MedTech Intelligence | August 2020

Managing Testing Strategies Under the EU MDR

Medical Design & Outsourcing | August 2020

Exceeding Regulatory Requirements: Beyond the Checklist 

Medical Product Outsourcing | July 2019

The OEM’s Roadmap to Navigating MDR

Medical Product Outsourcing | June 2019

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

Med Device Online | May 2019

Preparing For MDR? Start With A Gap Analysis

MedTech Intelligence | February 2019

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

Medical Design & Outsourcing | November 2018

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


Medical Product Outsourcing | September 2020

Facts to Ensure MDR Success 

Orthopedic Design & Technology | August 2020

Avoiding Contradictions: Testing Advice for Manufacturers 

Today's Medical Developments | June 2019

Regulations: Preparing for the EU’s MDR

Medical Design & Outsourcing | May 2019

How Should Medtech Manufacturers Cope With Sterilization Plant Closures?

Medical Device and Diagnostic Industry | May 2019

Is Your Testing Program Ready for the EU MDRs?

Medical Design & Outsourcing | April 2019

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

Medical Design Briefs | February 2019

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

MedTech Intelligence | November 2018

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