Content by Grant Ramaley

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Grant Ramaley
Medical device regulators around the world often have to assess the cost of a new regulation. Typically there is a study to determine the financial effect on industry and the public. This...
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Grant Ramaley
Congress has mandated that every two years the FDA will have inspected nearly every medical device manufacturer on planet Earth that sells to the United States. This isn’t happening. Some have the...
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Grant Ramaley
Electrically powered medical equipment will soon be subject to the Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU. As of July 22, 2014, most powered equipment sold within the...
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Grant Ramaley
Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent. A recent report published by...
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Grant Ramaley
Some European Commission notified bodies have been forcing a position that a medical device must conform to the latest technical standards to meet the European legal requirement for “state of the art...
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Grant Ramaley
One of the greatest challenges that I have in discussing standards is trying to put things in a context so that all people affected by them can understand how they matter. So I want to start with a...