Insights

Browse our collection of educational materials focused on industry trends, case studies and other content to keep you informed. 

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Newsletters

Explore articles crafted by our team of experts, covering pertinent topics related to regulatory affairs, quality management systems, and clinical affairs.

Case Studies

Discover real-life examples of projects we have undertaken, showcasing solutions implemented by AlvaMed to address challenges and deliver effective results.

WHO Launches the Medical Devices Information System

In a significant stride towards enhancing global healthcare standards, the World Health Organization (WHO) has

Draft Guidance on Use-Related Risk Analysis for Combination Products

In a significant move aimed at enhancing the safety and effectiveness of combination products, the

CDER Emerging Drug Safety Technology Program

The Emerging Drug Safety Technology Program (EDSTP) is dedicated to the integration of artificial intelligence

MHRA Proposes Stringent Requirements for High-Risk In Vitro Diagnostic Devices (IVDs)

In a bid to bolster patient safety and enhance regulatory oversight, the Medicines and Healthcare

MHRA Launches AI Airlock: Pioneering Innovation in Regulatory Oversight

The Medicines and Healthcare products Regulatory Agency (MHRA) has taken a bold step into the

ACLA’s Bold Move: Challenging FDA’s Final Rule on LDTs

In a groundbreaking legal maneuver, the American Clinical Laboratory Association (ACLA) has filed the first

The EU AI ACT: Implications for the Medical Device Industry

The European Union’s recent strides in regulating artificial intelligence (AI) have garnered significant attention, particularly

Definitive MDSAP Program Update Webinar

Definitive mdsap program update webinar Simplify the intricacies of MDSAP with actionable insights and expert

Accelerating Clinical Trials in the EU: Two Pilots Go Live

Clinical trials are the cornerstone of medical innovation, driving the development of new treatments and