Access our full library of guidance, white papers, and other resources developed by and for the medical technology industry.
This publication series explores “Software as a Medical Device (SaMD),” its challenges and the ways regulatory bodies try to address them, as well as the expected development of regulations related…
Sidley’s Global Life Sciences group looks at 12 forces driving the life sciences legal and regulatory landscape in 2022, and provides practical tips on a range of topics for life…
This white paper discusses the quality and regulatory approach for medical devices and software tools that contain AI/ML-based software.
This white paper explores how to best utilize CAPAs in the medical device industry including best practices, common pitfalls, and how to avoid “death by CAPA”.
Proper servicing of complex, life-saving medical devices is vital to their safe and effective functioning and the safety of patients and device users.
Brought to you by AdvaMed, Medtech POV with Scott Whitaker is a podcast that covers the intersection of medtech and policy from every perspective.
This white paper covers the history and evolution of quality systems and their application to medical devices.