The Risk Illusion - Wictome, Matthew
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The Risk Illusion: Seeing Beyond Compliance in a Regulated World Every organisation manages risk - but few truly understand it. In regulated industries, risk management often becomes a paperwork ritual rather than a thinking process, creating the comforting illusion of control while real vulnerabilities go unseen. The Risk Illusion explores why this happens - and how to fix it. Drawing on two decades of experience across global medical device and diagnostic companies, Matthew Wictome examines: * Why compliance-focused risk systems create a false sense of security * How ISO 14971 and FMEA are…mehr

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The Risk Illusion: Seeing Beyond Compliance in a Regulated World Every organisation manages risk - but few truly understand it. In regulated industries, risk management often becomes a paperwork ritual rather than a thinking process, creating the comforting illusion of control while real vulnerabilities go unseen. The Risk Illusion explores why this happens - and how to fix it. Drawing on two decades of experience across global medical device and diagnostic companies, Matthew Wictome examines: * Why compliance-focused risk systems create a false sense of security * How ISO 14971 and FMEA are misunderstood and misapplied in practice * The cultural and leadership blind spots that turn technical risks into organisational ones * Practical methods to integrate risk thinking into design, CAPA, suppliers, and post-market systems * How to build learning organisations where risk management drives confidence, not bureaucracy Whether you're a quality professional, technical leader, or executive accountable for compliance, this book challenges you to rethink what "managing risk" really means. Risk isn't something to be eliminated - it's something to be understood. The Risk Illusion shows how to move from documentation to dialogue, from compliance to confidence, and from the illusion of safety to the reality of understanding.