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A monthly analysis of the medical device industry, quality and regulatory developments, and other useful information for industry professionals. (Contact details are never shared outside our organization.)

Definitive MDSAP Program Update Webinar

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

Upcoming Regulation 2023/607 Transitional Provision Deadlines for MDR

On March 15, 2023, citing the impact of the COVID-19 pandemic, the lack of designated

Regulatory Science Tools Catalog

On May 13, 2024, FDA’s Office of Science and Engineering Laboratories (OSEL) launched an improved

FDA Issues Remanufacturing Guidance

On May 10, 2024, the FDA issued a guidance document on “Remanufacturing of Medical Devices.”

FDA Issues Final Rule on Laboratory Developed Tests

the FDA clarified that In vitro Diagnostic Devices (IVDs), including Laboratory Developed Tests (LDTs), are

CDRH Unveils New Dataset to Help Improve Chemical Characterization Methods for Biocompatibility of Medical Devices

FDA’s Center for Devices and Radiological Health (CDRH) is unveiling a new public dataset designed

FDA Launches Health Care at Home Initiative to Help Advance Health Equity

U.S. Food and Drug Administration announced the launch of a new initiative, Home as a

CDRH Issues 2024 Safety and Innovation Reports

The FDA’s Center for Devices and Radiological Health (CDRH) announced the release of its 2024

Navigating the EU Clinical Trials Regulation (CTR)

The European Union Clinical Trials Regulation (EU CTR) represents a landmark shift in the regulation