Securing the future: why medical device cybersecurity is no longer optional

As medical devices become increasingly interconnected and software-driven, cybersecurity is emerging as a critical pillar of product safety, compliance, and performance. From infusion pumps and patient monitors to remote diagnostic tools and AI-powered decision support systems, modern medical technologies are vulnerable to cyber threats which may put patients at risk.

In Coauthor’s first whitepaper in our new medical device cybersecurity series, we explore the evolving cyber threat landscape and what it means for manufacturers, developers, and compliance teams. Packed with expert insights and up-to-date case studies—from NHS ransomware attacks to FDA vulnerability notices—this whitepaper provides a comprehensive yet practical guide to understanding

and managing cybersecurity risks in today’s complex regulatory environment.

The whitepaper breaks down:

• The latest regulations and global frameworks, including MDR Annex 1, FDA guidance, and IEC 81001-5-1

• Cybersecurity integration across the product lifecycle, from Secure Software Development Lifecycle (SDLC) to post-market surveillance

• UK-specific standards such as DTAC, DCB 0129, and the DSP Toolkit

• Supply chain risks, the role of Software Bills of Materials (SBOMs), and cloud-based vulnerabilities

• Common myths about cybersecurity (and how they can delay or derail compliance efforts)

• Actionable recommendations for embedding security into design, development, and monitoring workflows

Whether you're developing software as a medical device (SaMD), managing a connected device portfolio, or simply trying to stay ahead of changing compliance requirements, this whitepaper is a valuable starting point.

Access the full whitepaper and discover how your organisation can reduce cyber risk, maintain regulatory compliance, and design safer, smarter medical devices.