Background
Mike Goodson has over 11 years of experience and expertise in medical device regulatory affairs. He’s a seasoned regulatory affairs expert with competency in U.S. and international regulatory including 510(k)s, PMAs, IDEs, and EU Technical Documentation including Clinical Evaluation Reports.
As Senior Director of Regulatory, he specializes in regulatory strategy, writing regulatory submissions, performing gap analyses, developing technical documentation and clinical evaluation reports to meet European regulations, pre- and post-market clinical data collection strategy, clinical data assessments, and performing comprehensive literature searches and analyses.
Education
Mike received his Bachelor of Science from Fontbonne University with a concentration in business administration and marketing.
Experience
Before joining MCRA in 2017, Mike was a Senior Specialist, Regulatory Affairs where he successfully developed EU technical documentation to obtain CE marking under the for both high-risk and low-risk medical devices. Mike led the development of gap analyses and transition plans to facilitate compliance from the EU MDD to the new EU MDR. Mike also prepared over 100 international medical device applications to the EU, North and South America, the Middle East, and Asia-Pacific markets.
Overview
Mr. Goodson’s work at MCRA focuses primarily on international regulatory across various device types in orthopedics, spine, cardiovascular, neurology, wound care, and dental.