SaMD Diabetes Software Experts

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Sara Seitz

Diabetes SaMD: Important
Considerations for Developing
Successful Interoperable Solutions

Diabetes is a condition that requires significant management. It is this extraordinary workload that has many people with diabetes turning to high-tech devices to help them manage their health and keep their blood sugars within a more normal range. This trend toward a greater reliance on personal medical technology is growing throughout the medical industry. In fact, MarketsandMarkets has projected that the Internet of Medical Things (IoMT) market will grow at a compound annual rate

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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.

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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.

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Advancements & Opportunities in Continuous Glucose Monitoring

Current research into improving the accuracy and usability of continuous glucose monitors has left few stones unturned. From sweat-based sensors to contact lenses, boundless opportunities are waiting to be explored in this arena. Find out which of those opportunities holds the most promise and how your company can capitalize on advancements in this technology.

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Opportunities in Remote Patient Monitoring and Cloud Connected Apps

The remote patient monitoring niche is growing thanks to advancements in technology and an increased reliance on remote care. From continuous glucose monitors to innovative cloud-connected devices, the diabetes arena, in particular, offers many opportunities for companies with the right ideas and the right technology to find success.

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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.

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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.

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CGM Applications Beyond Diabetes Monitoring

Continuous glucose monitors have left the world of diabetes care and entered a new niche in the fitness market. But the usefulness of CGMs in people without diabetes still has not been fully realized. Find out what opportunities exist in this growing niche and how innovative companies like yours can capitalize on them.

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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.

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Global Harmonization of Med-Tech Quality Guidelines

Creating medical technology for the world market requires meeting various regulations set forth by different governing bodies. Here we look at how global harmonization of med-tech quality guidelines has made this process easier and where divergences still exist.

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Diabetes and Pregnancy: An Open Niche for Software Development

Good management of blood sugar while pregnant is paramount for positive outcomes, but current technology doesn’t do enough to help expectant mothers with diabetes reach this goal. Here, we look at the opportunities for software and medical tech development in this field and why filling these gaps is vital.

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SaMD Diabetes Software Experts

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