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Regulatory/News

Our goal through these challenging times is to provide educational updates and continue evolving our partnership through additional services. We are in this together.

Not only are we your testing partner, we also have international regulatory experience. We can very quickly see trends and adapt to those changes as they come.

Sandi Schaible
Senior Director, Analytical Chemistry and Regulatory Toxicology

White Papers

Unknowns are Unacceptable

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Mitigating the Impact of an FDA Warning Letter

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Articles

Medical Design & Outsourcing: Pre-clinical medical device testing under ISO 10993-1 and the MDR

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Med Device Online: Preparing For MDR? Start With A Gap Analysis

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Regulations: Preparing for the EU’s MDR

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

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

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MD+DI: Is Your Testing Program Ready for the EU MDRs?

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The OEM’s Roadmap to Navigating MDR

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

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

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

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How should medtech manufacturers cope with sterilization plant closures?

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