Cook Medical Partnering With Regulators

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Bloomington-based Cook Medical is joining an international collaboration involving medical device companies and regulatory agencies. The Medical Device Single Audit Program is designed to focus on patient safety without putting excess regulatory burden on companies. The need for a program to work with industry to oversee medical device manufacturing was brought up in 2012 at the International Medical Device Regulators Forum.

Regulatory agencies from the United States, Canada, Australia, Brazil and Japan are taking part in the collaboration.

Cook Medical President Pete Yonkman calls the approach “very exciting,” saying it will lead to better use of regulatory and company resources. The company's plant in Limerick, Ireland recently took part in a two-day trial of the new auditing approach.