If you are finding some extra time for prototyping new designs and side projects, you may be searching for third party/open source software to make rapid progress. Alex shares a few key considerations when selecting open source software to incorporate into your code set. If you need assistance in designing and developing source code for […]
With a variety of tools and best practices to contribute to the delivery of quality code, we are highlighting one of our preferred practices, static analysis. Dave explains what static analysis is and when you should be using it. If you would like to learn more about software development testing best practices, please schedule a […]
Unit testing is a critical component of the software development process; however, few build and execute them in an effective and efficient manner. Dave and Rightley discuss automated unit tests and their benefits. Want to learn more about the benefits of automated unit tests? If you are not sure where to begin, or need assistance […]
In this video, we address device classifications, software safety classifications, and level of concern, as it relates to medical device development. We discuss each framework and how each is classified and what each classification means and determines in the product development process, and more specifically, what is required for a 510(k) or PMA submission. […]
Developing Successful FDA Compliant Medical Devices Software and Firmware for Safety-Critical Systems Today, medical devices rely on an increasing amount of software running on embedded microprocessors, PCs, smartphones, and the cloud. Whether you are designing and developing standalone Software as a medical device (SaMD), networked medical devices, a component of an IoT system, or a […]
Arguably one of the largest concerns regarding the Internet of Things (IoT), cybersecurity is a hot topic when it comes to developing a new product. Products connected to the IoT, or communicating with a larger network of devices, are often vulnerable to external technical attacks. These attacks cause the device to malfunction or work against […]
The Master Test Plan (MTP) defines the general approach to testing at the architectural level within a device’s software. This document applies to the product’s software testing as a complete platform. It addresses testing of the product’s software and its components to understand the extent of testing necessary to ensure the software performs as required. […]
The Software Development Plan is the planning document for the development of software and software support for a product. It provides an overview of software development, describes how the project is managed, how work is conducted, and how the development process is tailored to meet applicable standards, requirements, and objectives. This includes a description of […]
During the project planning phase, the two most important components are the product requirements and the architectural design. These components create a clear vision for how the product should be engineered. The goal of the architectural design specification (ADS) document is to define the platform software architecture and to provide an assessment of the impact […]
The purpose of a Quality Assurance Plan is to define the general approach taken to ensure quality throughout the product development process. It should cover all basic information concerning review, development, and planning for verification, validation, and proving the system can provide the level of support required by the product while minimizing the chance of failure. […]
