When a medical device causes harm, plaintiff’s attorneys and regulators ask a common question: could and should this device have been made safer? Risk management files, design history files, and post-market records become the roadmap for reconstructing the manufacturer’s safety reasoning.

This presentation offers a legal lens on medical device safety by showing how those records are read in both litigation and regulatory enforcement. From the perspective of a plaintiff’s attorney, the case often turns on four questions: (1) Did the manufacturer diligently identify hazards and estimate the associated risks? (2) Did they earnestly reduce those risks through reasonable design changes and risk controls? (3) Did they adequately test and verify the risk control measures? (4) How well did they conduct post-market surveillance and detect signals that indicate patient harm?

The talk then turns to the enforcement perspective: how FDA and other regulators rely on post-market data, inspections, and documentation in the risk management file to decide on enforcement actions.

By contrasting “check-the-box” compliance with a truly defensible risk management file, this session will help device professionals understand how their documentation is evaluated, and how to build records that both promote safer devices and withstand legal and regulatory scrutiny.