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1Blog Post

The Rapid Rise of Digital Health Technology: Challenges and Keys to Success

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What is Digital Health? Digital health merges digital technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery to make medicine more personalized and precise. Digital health is a broad category that includes: Mobile health (mHealth) Health information technology (IT) Wearable devices Telehealth Telemedicine Personalized medicine Digital health technologies use: Computing […]

2Blog Post

Ensuring FDA Compliance for Your Digital Health Solution

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Over the last decade, digital health solutions have become increasingly important, powering revolutionary developments in areas such as robotics, genomics, diagnostics, patient/provider interactions, and many more. In our recent webinar with MDM Engineering Consultants and BeanStock Ventures, we talked about critical standards and best practices to follow. Attendees also heard critical insight from industry leaders […]

3Blog Post

Software as a Medical Device (SaMD): Four Key Development Best Practices

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This post on Software as a Medical Device (SaMD) development is written by Mercedes Massana, the Principal Consultant of MDM Engineering Consultants.  SaMD software is software intended to be used for one or more medical purposes that do not require embedding in a medical device. These purposes can range anywhere from helping to diagnose or […]

4Blog Post

Regulatory Shift for Machine Learning in Software as a Medical Device (SaMD)

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Machine Learning in Software as a Medical Device Machine learning (ML), a subset of artificial intelligence, has become integral across software in all industries, and the medical and life science spaces are no exceptions. ML can help medical systems improve the identification and diagnosis of disease, create personalized medicine, and help with drug discovery and […]