July 2013

For Medical Device Companies

Ten Points for Successfully Addressing Warning Letters

by: Maria Fagan, Regulatory & Quality Solutions LLC

Maria Fagan shares ten common-sense points to remember while establishing a constructive working relationship with the FDA and moving forward with better business practices that are balanced and compliant to regulation.

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Using History to Predict the Future of Quality

by: Tim Donaldson, Donaldson Group, Inc.

Predicting the future is fool’s play---think Edsel, Nostradamus, even Chicken Little. But if you or your organization is wrestling with what direction to take your quality programs and your entire organization, perhaps a brief look at history will aid in developing your future strategies and culture of quality.

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What’s Really Important in Supplier Quality Controls?

by: Heather Thompson, MD+DI

Supplier management is about a balance of controls, Brian Dense told a lunch and learn group during MD&M East this week. Medtech companies need to assess the trustworthiness of suppliers and react accordingly.

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