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Risk Assessment Standards & Procedures

Butler Snow LLP

Can What the Supreme Court Said About Device Clearance in Lohr, a “Derelict on the Waters of the Law,” Finally Be Sunk?[1]

Butler Snow LLP on

Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more

Holland & Knight LLP

Establishing an Effective Compliance Program: An Overview to Protecting Your Organization

Holland & Knight LLP on

In This Issue: - Overview - Standards and Procedures - Organizational Leadership and Culture - Reasonable Efforts to Exclude Bad Actors From Managerial Ranks - Training and Education - Monitoring,...more

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