In the MedTech industry, information security is not just an IT issue – it’s fundamental to patient safety. MedTech companies handle sensitive product data, patient information, intellectual property, and regulatory documentation. A single data breach can jeopardise trust, compliance, and business continuity.
An Information Security Management System (ISMS) in accordance with ISO/IEC 27001:2022 provides a risk-based framework for the systematic identification, evaluation, and control of information security risks. Importantly, ISO 27001 follows the same structure as ISO 13485, enabling easy integration into your existing QMS.
If you already operate a QMS under ISO 13485, you’ve done much of the groundwork. In our latest whitepaper, our Executive Board Member Jörg Dogwiler and esteemed colleague Daniel Ziegelmayer, COO at mdeg, demonstrate how to leverage what you already have – and how to build what’s missing, with minimal friction.
Download the free resource below to discover how to implement an ISMS according to ISO/IEC 27001 and seamlessly integrate it into your existing ISO 13485 QMS.
And should you have an ISMS challenge, feel free to get in touch with our team of MedTech experts.