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Software For Medical Devices Articles & Analysis

4 articles found

Newly Released FDA Guidelines for Sepsis Detection & what it Means for Hospitals

Newly Released FDA Guidelines for Sepsis Detection & what it Means for Hospitals

John Halamka, M.D., president, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, Mayo Clinic Platform; "The term software as a medical device (SaMD) may sound cryptic to anyone not familiar with health care IT. ...

ByAmbient Clinical Analytics


Familiar but Mysterious: Understanding Software as a Medical Device

Familiar but Mysterious: Understanding Software as a Medical Device

As technology continues to advance software has become an important part of most products. It has become integrated widely into medical platforms. In 2019, the Software as a Medical Device (SaMD) market was estimated at about $18.4 million, and it is projected to reach $86 million by 2027 at an annual growth ...

ByBioT Medical


The Source for Respiratory Innovation Secured- KoKo, LLC and Galen Data

The Source for Respiratory Innovation Secured- KoKo, LLC and Galen Data

KoKo, LLC is a leader in pulmonary diagnostics and monitoring of chronic lung disease whose expertise is already being used at major medical centers around the world. KoKo’s commitment to upholding personal health information security protocols connects well with Galen Data’s 40+ years of experience with medical device ...

ByKoKo PFT


A Quick Overview of ISO 13485 Requirements for Medical Device Companies

A Quick Overview of ISO 13485 Requirements for Medical Device Companies

It is an undeniable fact that safety and quality are the top-most priority for medical device companies. However, the best-practices to maintain these priorities are defined under ISO 13485. ...

ByQualityze Inc

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