Knowledge center

Home
Knowledge center

Show: All / Whitepapers / Webinars / Articles / Flyers / Blogs / Podcasts / Documents

Category:

Show content from:

Date

Search

Highlights

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.

FDA In-Vitro Diagnostics Quality Regulatory Affairs

January 24, 2024

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

Blog FDA Medical Devices

Results

The Role of Biological Risk Management in Medical Device Development

The biological evaluation of medical devices, guided by ISO standards, must be integrated into the risk management process to ensure comprehensive consideration of biological risks, a task often challenging for manufacturers but addressed by Qserve through expert collaboration, structured assessment, and data integration for enhanced safety evaluation and testing.

Biocompatibility Medical Device Regulations Medical Devices Risk Management

Q&A: Chinese Medical Device Regulations NMPA

The most common questions and answers about market access in China. In this whitepaper 21 questions will be answered about the Chinese Medical Device Regulations NMPA. Everything you need to know about Medical Device Registration in China.

China China Agent Global Registration Market Access China Medical Device Registration NMPA Whitepaper Highlights

Countdown to Compliance: Safeguarding Your EU Market Access in Less Than 100 Days – Stay on Track!

As the May 26, 2024, deadline for EU MDR transition approaches, regulatory compliance becomes paramount.

Medical Device Regulations Medical Devices Highlights

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.

Medical Device Regulations Medical Devices Regulatory Affairs

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).

CE Certification Clinical Investigation Europe In-Vitro Diagnostics IVDR Post Market Surveillance Regulatory Compliance Technical Documentation Vigilance

1 2 3 4 5 ... Next