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Setction Meeting: New Regulations for Managing Risk and Clinical Issues Aimed at the design of Medical Device

Many of us work in a regulated environment.  Very recently the medical devices have come under the scrutiny of the Health Authorities. Please attend this meeting to find out what happened, what is being done about it and how pertinent regulation have been changed. Many of you probably don’t know what a medical device is.  Believe or not a felt tipped pen would be considered a medical device if a surgeon uses it to draw on a patient to indicate an incision point.  Come to this meeting and be educated as to new ideas and trends .

Presented by:  Nancy J. Sperling, MS QA/RA, Green Belt and CQA

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