Tools and building blocks to address new medical device design challenges

Medical apps on smartphones and smartphone-like platforms are driving growth in medical devices development. Are the tools available now adequate to deal with the serious safety and security issues involved?

Building Class III Medical Software apps on an Android Platform, Part 1: A case study

The authors describe the software development of an FDA compliant Class III medical software application that was successfully ported from a Windows CE environment to an Android 4.1 tablet platform.

Building Class III Medical Software apps on an Android Platform, Part 2: Developing an FDA-compliant framework

In the second in a two-part series, the authors describe the lessons learned about how to coordinate in-house and out-source components and expertise without affecting design goals.

Using domain-specific modeling languages for medical device development

How existing languages for Programmable Logic Controllers (PLCs) can be extended with domain-specific constructs for medical devices and used to generate native code that runs on both Intel and ARM processors.

Electronics for the Sick

Medical devices should be of interest to any embedded software developer as they encapsulate a great many of the techniques that characterize modern embedded systems development.

An Android-Based Body Area Network Gateway for medical applications

A Body Area Network (BAN) gateway to Android mobile phones for mobile health applications based on a Secure Digital Input Output (SDIO) interface.

Evaluating the software security of medical devices

Analysis of the security of software that controls a modern Automated External Defibrillator (AED) used for cardiac arrhythmias revealing several vulnerabilities including acceptance of counterfeit firmware updates.

Five steps to creating reliable medical devices

Ravi Patel describes a holistic approach to the systems engineering and software development of a medical device.

Sensor fusion brings situational awareness to health devices

A data-centric sensor fusion architecture is essential for building situationally-aware applications.

Using formal methods for sophisticated static code analysis

In this Product How-To design article, Jay Abraham of Mathworks uses the company’s Polyspace code verifier to explain the use formal methods-based static code analysis to ensure high quality and verifiable embedded software.

Using static analysis to evaluate software in medical devices

Researchers at the FDA's Office of Science and Engineering Laboratories investigating new techniques for analyzing software in medical devices are using static analysis tools to uncover potential flaws in a device under review.

A Formal Methods-based verification approach to medical device software analysis

How to use formal methods"based abstract interpretation techniques to mathematically prove the absence of a defined set of run-time errors and a comparison with techniques as code review, static analysis, and dynamic testing.

Educational Resources

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