Michael Wienholt

Michael joined Halloran Consulting Group in 2015. Despite his youthful look, he brings more than 25 years of experience in the medical device industry to his client engagements, including 15 years of experience in global regulatory affairs and quality management systems for medical devices and in vitro diagnostics. Michael provides expertise in regulatory strategies and submissions and the design, implementation, and audit of quality management systems. Clients also benefit from his uncanny ability to weave quotes from movies into conversations in a very appropriate way.
Prior to joining Halloran, Michael was the owner and principal consultant at FDA Consulting LLC where he built a reputation as a go to person for resolving sticky regulatory situations. His reputation for doing the right thing preceded him to Halloran as he came highly regarded from industry personnel and FDA contacts.
Michael earned a Bachelor of Science degree in Forestry from North Carolina State University. He is Regulatory Affairs Certified (RAC) in both US and EU regulatory requirements by the Regulatory Affairs Professional Society (RAPS). He is also an ANSI-RAB-accredited lead auditor for medical device quality systems.