medical device software Articles
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The Source for Respiratory Innovation Secured- KoKo, LLC and Galen Data
KoKo, LLC announces a partnership for access to Galen Data’s cloud platform. This new partnership provides KoKo direct and secure connectivity to a compliant cloud infrastructure, allowing access virtually anywhere. The secured data can be made accessible to providers and patients. By harnessing this information, KoKo will be able to develop innovative respiratory health solutions that ...
By KoKo PFT
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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 rate of 21.9%. As one of the fastest growing sectors in healthcare, we explore when ...
By BioT Medical
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Regulatory Landscape Continues To Influence Product Recalls
Product recalls may be the least welcome part of the quality landscape, but companies that don’t put the right strategies in place to prevent these events happening are likely to keep repeating the same compliance and poor quality mistakes. The latest quarterly report from recall solutions and quality audit provider Stericycle bears out the common wisdom that recall-related headlines about ...
By EtQ, LLC
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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. You cannot brush aside the need for implementing the right enterprise quality management software to create and maintain the culture of quality and continuous improvements. The software may help you meet ...
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Newly Released FDA Guidelines for Sepsis Detection & what it Means for Hospitals
Executive Brief On September 28, 2022, the FDA released Clinical Decision Support, Guidance for Industry and Food and Drug Administration Staff. This guidance is long overdue, and with it comes the elimination of any protections for EHRs, or any other vendors, to pretend it’s OK to sell or deploy solutions for patient monitoring and care for life-threatening conditions like sepsis, that ...
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