Using Software Emulators to Expedite Product Delivery
Software emulators provide a virtual world to test software-hardware interactions to reduce risks and expedite development. Find out what emulators are and what other advantages they hold for your medical device company.
Software as a Medical Device – Part II: Development & Regulation
Software as a medical device has its own development needs and regulatory guidelines. Find out what qualifies as SaMD, the best practices for developing it, and how to do so in line with regulatory guidelines.
Software as a Medical Device – Part I: What Is SaMD?
Software as a medical device has its own separate definition according to most regulatory bodies. Find out if your medical technology qualifies as SaMD in Part I of our software as a medical device series.
Medical Tech Software Safety and IEC 62304
IEC 62304 is an important standard for the planning, development, and launching of safe medical software and software-based medical devices. Find out how this functional software lifecycle standard helps deliver safe medical tech that aligns with national regulations.
Understanding & Implementing ISO 14971 for SaMD Development
ISO 14971 is a vital tool for the design and development of safe and effective medical technology software. Find out what this standard consists of and how you can put it to use to streamline your risk management process.
Mobile Medical Applications: What Is NOT Considered an MMA
Many mobile apps used in the healthcare industry and by patients are not subject to FDA regulations. Find out if your new software project is considered a mobile medical application or not.
What Are Mobile Medical Apps & How Are They Regulated
Mobile medical apps play an integral role in connecting patients, doctors, and medical devices. Find out what qualifies as an MMA and how the FDA regulates this type of software.
The Importance of Agile Development in SaMD
To succeed in the ever-evolving medical technology and SaMD landscape you need a development process that’s flexible, less risky, and capable of producing superior products. Find out how Agile software development does that and more.
Developing SaMD in Conformance with ISO 13485
ISO 13485 provides valuable guidance to create effective quality management systems for your medical technology company while ensuring compliance with global regulations. Find out everything you need to know about this QMS standard and how you can use it to help your SaMD company.
Component Architecture: A Necessity for SaMD Development
Component architecture provides a flexible, versatile framework for medical technology while lowering risk. Given how quickly the med tech world is evolving, building software with these kinds of characteristics is a must. Find out what component architecture is and why it’s the only option for SaMD and medical software companies.
Software Development Kits (SDKs) and the Future of Software as a Medical Device (SaMD)
We will soon have more ways to measure health than we have platforms to present the data. That is why every medical technology company should be focused on integration and partner enablement. Find out why software development kits are key to opening the doors to integration and how they can help you achieve greater marketshare.
New Trends in Wearable Medical Devices
From patches that can sense multiple metabolic and hemodynamic parameters to CGMs meant for non-diabetics, wearable medical devices are entering a new phase. Here, we look at current products in the works and what else might be on the horizon.
The Intrusive Nature of Remote Monitoring: How to Strike a Balance
Remote monitoring offers a huge number of benefits to both patients and caregivers. But the medical devices and tech used to create RPM can easily become intrusive. In this article, we look at how med tech companies can strike a balance.
The What, Why, and How of Diabetes-Tech Interoperability
In today’s market, diabetes technology needs to come with a high degree of interoperability. In this article, we look at what interoperability is, why it is so important, and how you can create software and devices readymade to connect.