---
title: "Secure by Design: Using Hardware and Software Protection"
description: This webinar, the third in our series focusing on medical device cybersecurity, reviews what it means to take a “secure-by-design” approach, which the FDA sees as a necessary part of a design process compliant to quality system regulations 21 CFR 820.30(c) and (d) and is highlighted in their cybersecurity pre-market guidance. This webinar provides an overview of hardware protection such as Secure Boot, HSMs, TPMs, that should be considered when security is being “built in”, and security software such as Trusted Execution Environments (TEEs), and Intrusion Detection Protection Systems (IDPS) that complement those hardware features. These security controls address seven out of the eight control categories the FDA is looking for in pre-market submissions including authentication, cryptography, code/data/execution integrity, confidentiality, event detection/logging, and resiliency and recovery.
---

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# Cybersecurity in Medical Devices: Practical Advice for FDA’s 510(k) Requirements Secure-by-Design: Using Hardware and Software Protection for FDA Compliance

The third in our series on medical device cybersecurity, this webinar explores the “secure-by-design” approach to medical device software development. The FDA considers this approach integral to a design process compliant with quality system regulations 21 CFR 820.30(c) and (d) and is highlighted in their cybersecurity pre-market guidance.

The FDA expects device makers to address multiple control categories in their pre-market submissions. Whilst in principle you could address all from scratch, a more practical approach is to leverage hardware capabilities and third-party security solutions to ensure compliance and enhance the overall trust and reliability of your products.

During this important session, we will:

- Outline which security measures should be considered for compliance
- Identify technical solutions available on various hardware platforms
- Summarize hardware protection methods (e.g. Secure Boot, HSMs and TPMs) you should consider when building in security
- Review security software such as Trusted Execution Environments for secure storage of keys and data, and Intrusion Detection Protection Systems to monitor for threats

Join us to learn more about how these technologies can make your devices compliant with the new FDA cybersecurity guidelines.

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## About The Presenters

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### Milton Yarberry ICS

Milton is the Director of Medical Programs for ICS. He is a certified PMP and Scrum Master with a background in software architecture, medical device product development and program management. He has 20 years in product development with 10 years in software consulting and 15 years working with Class II and Class III medical device manufacturers.

### Colin Duggan BG Networks

Colin is the founder and CEO of BG Networks. Before founding BG Networks in 2020, Colin worked at Analog Devices (ADI) for 29 years in various engineering, management, and marketing leadership roles managing teams located in U.S., China, Europe, and India. Colin’s experience includes work in automotive, consumer, industrial, and aerospace & defense markets.

### Richard Hayton Trustonic

Richard is Chief Strategy and Innovation Officer, Secure Platform at Trustonic. With over 30 years in the cybersecurity industry, he is a regular speaker and influencer on matters of cybersecurity. Prior to Trustonic, Richard spent 20 years at Citrix Mobility, leading projects ranging from embedded software to global enterprise systems, with a focus on user and developer experience.

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