Expert Insights

Explore practical guidance to help medical technology teams reduce risk, make informed decisions, and bring life-changing products to patients faster.
Securing Your Medical Device Software Development Life Cycle
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Securing Your Medical Device Software Development Life Cycle

October 15, 2024 2 min read
The Seven Success Factors in Building a Robust Compliance Program Infrastructure
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The Seven Success Factors in Building a Robust Compliance Program Infrastructure

August 8, 2024 3 min read
Engaging a Penetration Testing Team
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Engaging a Penetration Testing Team

April 17, 2024 4 min read
Breaking Sterilization Barriers – EPA’s Bold Move Towards Safer Medical Device Regulation
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Breaking Sterilization Barriers – EPA’s Bold Move Towards Safer Medical Device Regulation

March 18, 2024 2 min read
EU AI ACT and Its Impact on the Medical Device Industry
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EU AI ACT and Its Impact on the Medical Device Industry

March 6, 2024 2 min read
NEW Draft Guidance from FDA – “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”
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NEW Draft Guidance from FDA – “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”

January 31, 2024 3 min read
European Commission Proposes to Extend IVDR Transition and Accelerate EUDAMED Adoption
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European Commission Proposes to Extend IVDR Transition and Accelerate EUDAMED Adoption

January 25, 2024 2 min read
FDA and Clinical Trials Transformation Initiative (CTTI) Collaborate to Improve ClinicalTrials.gov
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FDA and Clinical Trials Transformation Initiative (CTTI) Collaborate to Improve ClinicalTrials.gov

January 19, 2024 2 min read
MHRA Releases Roadmap of Future UK Medical Device Regulation
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MHRA Releases Roadmap of Future UK Medical Device Regulation

January 16, 2024 2 min read

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