Software-related medical devices are taking over the medical device industry. There are three types of software-related medical devices in the industry software as medical devices, the software is integral to medical devices, and software used in the manufacturer or maintenance of a medical device1. Software that is….
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The Role of AIML in Cervical Health
One of the main strategies to eliminate cervical cancer is the consistent screening of people with cervixes. However,...
EMMA International’s Body of Knowledge (BOK)
Do you enjoy all the content from EMMA International? We have good news for you! We are proud to announce that our...
Global Regulators publish Good Machine Learning Practices (GMLP)
It is no secret that AI/ML medical devices are under a special spotlight by international regulators this...
Innovative Computing Solutions and MedTech
The rapid expansion of computing is attributed to the consistent improvement in capabilities, speed, and performance...
Growth and Integration of ML/AI in Biotech
The biotechnology and pharmaceutical industries are heavily reliant on collecting, storing, and analyzing data for...
Software Systems: Medical Device or Not?
The 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...
Using AI to Predict Strokes
One of the major purposes manufacturers incorporate AI or ML in their applications is to ease software computations...
Employing AI to Diagnose Cancer
In my software engineering career, I was lucky enough to work on some amazing frameworks and technologies, but nothing...
Mobile Applications for Heart and Blood Pressure Monitoring
Nowadays, there are mobile applications for almost every utility and in every domain. From e-commerce, finance,...
Researchers Develop the New ML Tool for Predicting Progress in COVID-19 Patients
In the current Digital Age, we hear the term Machine Learning (ML) in almost every domain. But what exactly is ML?...
FDA Clarifies The Types Of MDSAP Audits To Be Conducted In The Pandemic
The FDA released an information transmittal to the MDSAP Auditing Organizations on December 31st, 2020 providing...
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