2023 Clinical 483 Inspection Observations Trends

First Quarter 2024 Clinical 483 Inspection Observations are Tracking to 2023 Trends. How to Stay Ahead with a Winning Strategy! Are you curious about different ways to avoid a 483 violation? Then this MEDIcept White Paper is for you!  Each year, FDA compiles a list of...

Building a Better SBOM with Build SBOMs

Dive into MEDIcept's latest white paper on Building Software Bills of Materials (SBOMs) to safeguard against cyber-attacks targeting Healthcare Delivery Organizations. Learn why SBOMs are pivotal for understanding and managing vulnerabilities in medical devices,...

EU AI ACT and Its Impact on the Medical Device Industry

The provisional agreement on the Artificial Intelligence Act proposed by the European Parliament introduces a unified regulatory framework for AI across the EU, with significant implications for the medical device industry. This paper aims to discuss the potential...