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February 26, 2024

Does the EU still foster innovation, and does it care about SMEs?

This blog discusses various topics related to medical device innovation, including challenges faced by startups, regulatory complexities, the impact of AI-enabled devices, the need for material innovation, and the importance of thorough clinical data collection for safety and compliance, emphasizing an integral approach to regulatory strategy and collaboration between companies and CROs.
February 16, 2024

Certification news | Regulatory Compliance Certification IVDR for Christie Hughes

Congrats to Christie Hughes, MPH, MLS(ASCP), RCC-IVDR, for achieving Regulatory Compliance Certification IVDR (RCC-IVDR) at Regulatory Affairs Professionals Society (RAPS).
February 09, 2024

FDA Quality Management System Requirements Proposal Becomes Final 

February 01, 2024

Navigating 2024: An Overview of the Upcoming Initiatives from FDA impacting Medical Device and IVD Manufacturers 

Although FDA’s fiscal year begins October 1st every year, now in 2024 significant FDA initiatives are set to reshape the landscape for medical device and IVD manufacturers. We're closely tracking the pending Quality System Regulation Amendments, the proposed Laboratory Developed Tests rule, the Diversity Action Plan for clinical trials, and the 2024 New Guidance Agenda. Read more below as Qserve's expert teams provide insights and assistance for navigating these regulatory changes. 
January 24, 2024

FDA Proposal to Change the Classification of Certain Wound Dressings, Topicals and Liquids