NEW Draft Guidance from FDA – “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”
NEW Draft Guidance from FDA – “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”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
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
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
MHRA Releases Roadmap of Future UK Medical Device Regulation
January 16, 2024
2
min read
Understanding Digital Health Technologies (DHTs) in Clinical Trials
Understanding Digital Health Technologies (DHTs) in Clinical Trials
January 2, 2024
2
min read
Understanding the Essentials of Clinical Investigation Under the EU Medical Devices Regulation (MDR): Insights from MDCG 2021-6 Update
Understanding the Essentials of Clinical Investigation Under the EU Medical Devices Regulation (MDR): Insights from MDCG 2021-6 Update
December 18, 2023
2
min read
Understanding FDA’s Guidance on Medical Device Export Certificates
Understanding FDA’s Guidance on Medical Device Export Certificates
December 5, 2023
4
min read
Managing Legacy Medical Device Cybersecurity Risks- What You Need to Know!
Managing Legacy Medical Device Cybersecurity Risks- What You Need to Know!
November 30, 2023
6
min read
FDA Recognizes NEW Key Cybersecurity Standard
FDA Recognizes NEW Key Cybersecurity Standard
November 14, 2023
4
min read