Existing literature on risk management for medical devices has been slow to adequately account for the complex nature of software in modern medical devices. Conversely, excellent progress has been made in the broader Software Engineering community with the production of holistic software risk based models such as the Capability Maturity Model Integration (CMMI®) and SPICE™. However, these models do not account for medical device specific requirements. This book examines the possibility of a unified approach whilst investigating the relevance of the CMMI® SPI model to the medical device regulatory requirements.
Invaluable to all practitioners, team leaders and managers in residential care, the Handbook provides a wealth of new ideas and many challenges to established policy and practice.
"I have always believed in God... but [one that] I had become slightly detached from. I could not make sense of God. Peter Thompson and later John Burton made God relevant, practical rather than theological. religion for me became less of a personal relationship with God. I began to see religion more as a social context." - Tony Blair
These words of Tony Blair's are revealing. His political life was always motivated by a profound sense of mission, which was fundamentally religious. Through encounters with the Australian Anglican priest at Oxford, Peter Thompson, Blair came to understand the history and continuing purpose of Christian socialism. His most important intellectual influence was the philosopher John MacMurray, whose writings Blair devoured. But it was through the author of this book, John Burton, that Blair came to understand the application of Christian socialist principles in action. The influence of his wife Cherie Booth's Catholicism also had a profound influence on Blair. Interviews with Cherie reveal her role in shaping his religious world view. Bill and Hilary Clinton are also shown to have played a formative role in Blair's ideological makeup. Blair's work in the Middle East may become the final and triumphant expression of his moral and religious principles. Many will find this hard to swallow in the light of Blair's actions in the Middle East whilst in office. Whatever viewpoint one takes on this complex moral issue, John Burton helps us to understand more deeply one of the most successful but enigmatic prime ministers of the post war years.
Extended examples and realistic case studies throughout demonstrate how managers can succeed and how sometimes the powerful forces of mismanagement can obstruct them.