Mike Begala - Senior Consultant, Quality Assurance & Regulatory Affairs

Mike has more than 14 years of experience in the medical device arena. In his role with Emergo, Mike assists medical device clients with a variety of quality assurance issues including ISO 13485 and FDA Quality System Regulation (QSR) compliance, auditing and training. He is well versed in the quality system regulations of the United States, Canada and Europe, and how those regulations overlap and differ from one another.

In addition to his experience in the QA arena, Mike also has extensive experience with regulatory affairs issues including the preparation of European Technical Files and US FDA 510(k) applications. His extensive knowledge of biocompatibility testing, sterilization methods and packaging compliance is also very useful for clients with products for which this is an important regulatory compliance issue.