Z-Tecknologie, S.P
Michael Zmuda, Ph.D., RAC, Principal Consultant
1998-present
ThermoGenesis Corp., Rancho Cordova, CA Vice President, Regulatory Affairs & Quality Systems
1997-1998
AMSCO International, Inc., Erie, PA Director, Corporate Regulatory Affairs & Quality Systems Director, Corporate Regulatory Affairs & Technical Support Director, Corporate Regulatory Affairs
1989-1996 1992-1996 1990-1992 1989-1990
CD Medical, Inc., Miami Lakes, FL Manager, Technical Services and Development
1986-1989
ImmunoMed Corporation, Tampa, FL Vice President and Director, Product Development
1984-1986
Baxter Travenol Laboratories, Deerfield, IL Manager, New Initiatives, Artificial Organs Division Manager, Materials Toxicology, Corporate R&D
1980-1984 1982-1984 1980-1984
Southern Illinois University School of Medicine Assistant Professor of Pharmacology
1975-1980
Education
Doctorate, Pharmacology, University of Minnesota Bachelor of Arts , Psychology, University of Minnesota
Publications
Medical Device Submission Procedures (Chapter 14), Medical Device
Compliance (Chapter 15), and Suspension & Withdrawal of Medical Device
Approvals (Chapter 20) in Fundamentals of Regulatory Affairs ,
Published by RAPS, 1999, Updated 2000, Rewritten 2001.
On the Road to CE Marketing: The Essential Requirements Matrix,
Regulatory Affairs Focus , 4(4), pp 19-22, Apr., 1999.
Compatibility Testing for Biological Products, Regulatory
Affairs Focus, 2(12), p 12, Dec., 1997.
Implementation of the Quality System Regulation, Regulatory
Affairs Focus, 2 (12), p 14, Dec., 1997.
Pharmacokinetics of hemoperfusion in drug intoxication (Kidney
Int. and Trans. ASAIO).
Several journal and conference presentations ( Am J Physiol,
JPET, ASAIO, J Fed Proc, et. al.)
