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Legal, Clinical & Regulatory

FDA and Customs Monitoring of International Purchasing: What You Need to Know

The ultimate goal is to ensure that all medical device products manufactured or distributed in the U.S. are both safe and effective for human use. 

The Medical Device Labelling Process Needs to Start Early in Design Controls

Mislabeled and misbranded medical devices are one of the top three causes for recalls in the United States. Companies can take several steps to minimize these mistakes — it comes down to being in control.

FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections

The rule amends that inspections will be risk-based, not biennial.