compliance

3 articles

Achieving Seamless Connectivity and Compliance for Mobile Healthcare

By Santhosh Nair For the makers of medical devices used in mobile healthcare, connectivity is becoming increasingly critical. Devices are becoming more intelligent and controlling more and more aspects of patient care, clinical diagnostics, and hospital administration. And they are interacting not just with people—expanding our ability to communicate and share information—but also with each other. They control systems that…

Qualifying Your Vendor

By Ken Herold Every medical device manufacturer marketing their device in the US must comply with regulations such as 21 CFR 820.50 Subpart E Purchasing Controls. This applies to all outside components they wish to incorporate into their device, including software. In part, this requires the manufacturer to: “(1) Evaluate and select potential suppliers, contractors, and consultants on the basis…

Highlights and hot topics from the Medical Devices Summit

By Santhosh Nair There were a lot of great takeaways from the Medical Devices Summit that I attended last week in San Diego.  Wind River solutions architect Pete MacKay gave an excellent presentation about medical devices design, cloud and Android that was very well received and Intel ECG presented on embedded security and isolation/protection in medical device design.  Wind River…