The main reasons for the general poor quality of medical software are lack of detailed specification by the user and inadequate software quality assurance (SQA) procedures employed by most developers. We have addressed these issues by (a) developing a set of basic user requirements for computer systems used in various branches of clinical physiology, aimed at improving the design aspects of medical software; (b) developing a general methodology for good manufacturing practice (GMP) in medical informatics, aimed at improving the production aspects; and (c) compiling a library of clinically validated reference data files, aimed at improving the field testing/validation aspect of nuclear medicine SQA specifically. Project deliverables deemed suitable for consideration as European standards were processed through CEN and EWOS.