The Risk Illusion

The Risk Illusion: Seeing Beyond Compliance in a Regulated WorldEvery 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 bureaucracyWhether 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.