The guidance on qualification and classification of stand-alone software has been updated. How does this affect remote patient monitoring systems?
In order to realize the full potential of remote patient monitoring systems, clinically proven AI is required.
Cloudflare had a large outage on July 2nd, 2019 and their post-mortem analysis is instructive from MedDevOps point of view.
The MEDDEV 2.1/6 guidance on qualification and classification of stand-alone software is being updated. How does this affect remote patient monitoring systems?
In remote patient monitoring systems, data integrity is crucial. Delivering wrong data could result in lack of necessary treatment, or in administering incorrect treatment.
During my years of developing a remote patient monitoring system at Nokia, I learned a few things about good development practices in a regulated environment.
MedDevOps has unique challenges with agile software development, documentation, procedures and overall effort.
MedDevOps is the practice of integrating medical device compliance into the DevOps way of working.
The purpose of this blog is to document my journey with medical device security and compliance, and to gather feedback from other medical software professionals.