Tips for a Successful Quality Audit
by Steve Ford, OMEDtech The medical device industry is a highly-regulated and constantly-evolving landscape, and, as a result of global and national regulations, there is an increased focus on auditing. It is critical to be prepared for third-party audits, as they are responsible for confirming your quality management system (QMS) compliance. Preventative audit
Medical device cloud security — protecting data
Protecting medical device data in the cloud Are you prepared for the shared responsibility of cloud security? Building cloud-based data collection for medical devices requires technical proficiency to make it work, and regulatory expertise to ensure clinical trial success and FDA clearance. A critical third factor is often overlooked: security to protect the da
What is a HIPAA-compliant cloud?
The shift to cloud computing began over a decade ago and has transformed nearly every industry. In the medical device sector too, there has been a steady increase in companies leveraging cloud connectivity for their devices. Potentially dealing with sensitive patient data and other Protected Health Information (PHI) means the existence of additional requireme
NIH and NSF Grants for Medical Device Startups
From concept to commercialization, the cost of launching a startup can seem overwhelmingly high. This reality is especially true for medical device startups, which require more capital than most prior to going to market. Thankfully, organizations like the National Institutes of Health (NIH) and the National Science Foundation (NSF) can help ease the initial cap
Implementing Medical Device Cloud Security
Buy vs. Build decisions cover myriad security issues and needs. Medical devices are increasingly becoming part of our daily lives. As they proliferate, the “bonus feature” of connectivity is quickly becoming a “must have” attribute for commercial success. Cloud connectivity helps meet the following market necessities: Collecting patient “vital sign”
How to Benefit from the New Medical Device Ecosystem
The New Medical Device Ecosystem: A transformation is underway in the realm of medical devices and medical sensor platforms — changing traditional definitions and creating new opportunities. In this report on Sensor Platforms, Cloud Connectivity, and the New Medical Device Ecosystem, we’ll define what constitutes an ecosystem and how medical device
Galen Data Partnership Protects Homebound Seniors During COVID-19
Homebound seniors with balance issues will benefit during COVID-19 from a new partnership between Galen Data and Zibrio. It’s the latest example of how medical device companies can take advantage of secure, scalable cloud connectivity. The patented Zibrio SmartScale measures physical balance and uses AI to predict an individual’s likelihood of falling &
Connected Medical Device Success Story: Advanced Telesensors
Galen Data’s partnership with Advanced Telesensors (ATS) is a connected medical device success story — demonstrating how early stage medical device companies can greatly benefit from the Galen Cloud turnkey solution. Austin-based startup ATS developed the Cardi/o® touchless monitor to remotely track vital signs of at-risk seniors living at home or
Telemedicine: Reaching Beyond Traditional Methods
How is telemedicine transforming beyond traditional applications? Here’s how data connectivity is powering a new wave of telemedicine use cases:
New Cybersecurity Requirements for MDR
New Cybersecurity guidance has been released for MDR. Kyle Rose of Rook Quality Systems gives us an overview...
