Are you compliant — but still feel blind to your real risks?

Does your risk-system generate documents more than decisions?

In this guide you’ll find: 

Why systems built to manage risk often end up masking it.

How culture, leadership and structure shape whether risk control succeeds or fails.

The hidden tension between compliance and true organisational resilience — and how to balance both.

Practical frameworks to integrate risk thinking into every part of your business: from design and CAPA to supplier management and post-market surveillance.

Case studies from regulated industries where risk management went wrong — and where it was done right.

Whether you’re a quality manager, technical leader, or executive responsible for risk and compliance in life-sciences or diagnostics, this book will help you see risk differently: not as a burden to manage, but as a strategic asset to understand.



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The Change Dilemma on your desk as your daily reference.