One of the primary outcomes of a software process assessment is visibility of the capability of a software process which among other things, informs us of the ability of a process to deliver consistent product quality levels. In safety critical domains, such as the medical device sector, high product quality – and particularly high product safety - is an important consideration. To address this safety concern, the medical device sector traditionally employs audits to determine compliance to software process standards and guidance. Unlike an audit which results in a pass/fail outcome, an assessment provides a process capability profile which identifies areas for improvement and enables a comparison with broader best practice. MDevSPICE® integrates the various medical device software standards and guidance within the infrastructure of a SPICE assessment model, thus encompassing aspects of compliance and capability. This paper describes some of the key enablers of this integration.