It’s nice to have medical device FDA regulations and guidance accessible without navigating through old websites or lugging printed copies around. Thankfully, SoftwareCPR’s free iOs and Android apps allow you to quickly view medical device regulations and guidance on your smartphone offline! As medical device consultants, we know from experience how important it is to...Read More
A short, short time ago, in this very own galaxy some companies were not making blockbusters, but medical devices. Whispers of quicker development times and better testing made the way past the water cooler until it became time to indulge and implement the mythical software development lifecycle. With the changes came weird language and rumors...Read More
Testing activities should neither end with the release of the product nor once test documentation is complete, but should continue with the reduction of any test debt. Test debt is essentially a form of technical debt. Like technical debt, test debt is incurred during a project when compromises are made in the creation of test...Read More
A security company indicated the following: … many companies received emails from Amazon indicating that their AWS S3 bucket policies were left configured as “publicly accessible”. These publicly accessible policies allow potentially sensitive cloud data exposed to cybersecurity threats, and likely are not the intention of the Amazon customers. Amazon recommended that each “bucket” policy...Read More
Since being introduced, test automation continues to evolve as new technologies are created and released. One such evolution is Ranorex Online which has been officially released for public beta testing. Those familiar with test automation are aware that browser plugins are a necessary evil for any web-based testing framework. Ranorex Online attempts to eliminate that...Read More
SoftwareCPR® is pleased to announce their Silver Service partnership with Ranorex®, an excellent test automation tool and company. You can read other posts on our site regarding Ranorex® here. As a silver partner, SoftwareCPR® is recognized as having the quality and experience needed for developing automated tests using Ranorex®, both in regulated and non-regulated environments....Read More
Our test team at SoftwareCPR® often uses Ranorex Automated Test Tool for automated integration level and software system level testing. We have had very good experience with this tools for user interface testing for certain types of medical device software. The test reports are particularly impressive and well suited for Design History Files (DHF). Accelerate testing...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.