Speaker Profile

Albert Cefalo

Regulatory Affairs Specialist, Analogic Corporation

Albert Cefalo, Regulatory Affairs Specialist, Analogic Corporation. Chuck has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career at Analogic he has involved in all activities related to Quality Assurance and Regulatory Affairs such as Creation and maintenance of SOPs, FDA, Health Canada and CCC submissions as well as served as Director of quality for several of Analogic's Business Units. Chuck also conducts in-house training on a variety of subjects. Chuck is the Regulatory Affairs representative on all of the Analogic Project Teams and provides an oversight of the Risk Management process.

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MDD Essential Requirements: An Overview

Any medical device manufacturer seeking market clearance in the European Community must meet and follow the Medical Device Directive or MDD. Since its original release in1993 there have been several updates to this directive, the most significant of whic

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