Author(s)

S.B. Leif, S.H.L. Aha & R.C. Leif

Abstract

Setting up a pre-production quality management process in the medical device industry S.B. Leif," S.H.L. Aha& & R.C. Leif" "Ada-Med, 1030 Mariposa Avenue, Coral Gables, F/on'do 33^, [/^ Software Engineering, Inc., 5303 Spectrum , Fredn'c&, MD ABSTRACT Medical device development and manufacture is a large, regulated industry. Medical devices now include a substantial software component which must be developed according to "good manufacturing practices." Good manufacturing practices require the definition and enforcement of software processes which ensure quality products by defining a detailed method of software construction. Although the technical problems of cre- ating a software process are significant, the political and human problems associated with its implementation are of greater difficulty. Our experi- ence with organizing the software process including the transfer of soft- ware technology from the defense industry to medical electronics wil

Keywords