Showing items related by title, author, creator and subject.

• Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive 

  Mc Hugh, Martin; Mc Caffery, Fergal; Casey, Valentine (The Institution of Engineering and Technology, 2012)

  A recent revision to the European Medical Device Directive (MDD) 2007/47/EC made fourteen amendments to the original directive (93/42/EEC). A number of these changes directly affect the development of software for use ...
• A practical application of the IDEAL model 

  Casey, Valentine; Richardson, Ita (John Wiley and Sons Limited, 2004)

  The focus of this paper is to outline the experience of a European based software organization utilizing the IDEAL model, while implementing a tailored Capability Maturity Model (CMM) software process improvement program. ...
• A critical evaluation of a methodology for the generation of software process improvement roadmaps 

  Flood, Derek; Mc Caffery, Fergal; Regan, Gilbert; Casey, Valentine (Springer, 2014)

  For medical device organisations to market their devices in specific geographic regions they must adhere to the regulations of that region. These regulations often recommend that organisations adhere to specific standards ...
• A methodology for software process improvement roadmaps for regulated domains – example with IEC 62366 

  Flood, Derek; Mc Caffery, Fergal; Casey, Valentine; Regan, Gilbert (Springer, 2013)

  Software process improvement initiatives offer many benefits in terms of productivity, cost savings and quality. As part of these initiatives or-ganisations undergo an assessment and then embark on a software process ...
• Verification & validation in medi spice 

  Sivakumar, M.S.; Casey, Valentine; Mc Caffery, Fergal; Coleman, Gerry (2011)

  Effective verification and validation are central to medical device software de-velopment and are essential for regulatory approval. Although guidance is available in mul-tiple standards in the medical device software ...