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
Seapine Software (seapine.com) which provides a variety of development tools published its 2014 report on the state of software development for medical devices. This report was generated based on input from 500 individuals in the medical device industry. It contains a breakdown of risk management methods used, key documentation challenges, requirements management approaches used, test...Read More
In SoftwareCPR’s experience, translations and localization of user interfaces and labeling of medical devices for distribution in a variety of geographic regions can be challenging and can present safety issues if not properly handled. Alan Kusinitz of SoftwareCPR® co-authored an article on localization risk management with one of the large companies that provides such services...Read More
In SoftwareCPR’s opinion, a somewhat unique, very well conceived, and well designed tool for the specialized craft of risk analysis as well as safety assurance cases. The tool is very configurable, allowing customized structures for your own methods. The ability to view data from an FMEA, FTA, or table view saves valuable time during creation...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
This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR suggestions for a validation or Part 11 master plan are that it be a high-level plan not providing detailed document or protocol formats. Generally it is best if a master plan is a transient document. It gets constructed...Read More
Need Your Input!
We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course? What are the least favored (not workable) months?