Our clients appreciate attention to detail and accurate execution. These recent publications can help you learn about our process.
Software developers can leverage workflow technology to solve recurring business problems in a re-usable way. Handling variances in test result calculations, report output format differences, and varying input file formats are problems easily solved by a workflow engine. Gain a better understanding and benefit from RND Group’s practical tips on use of workflow technology.
Are you a maker of an IVD medical device? Are you interested in shortening the time to release new clinical tests for your device? Learn about the importance of software architecture to enabling management and release of multiple clinical tests on an IVD device.
The road to FDA approval for your medical device can be challenging to navigate. Verifying that your solution is compliant with FDA standards and regulations ahead of time can help you approach the formal submission process with fewer risks and greater rewards.
Is your software project meeting its regulatory requirements? Does your software development life cycle employ industry best practices? Will your design history file contents be correct and of the quality needed for FDA submission? How do you know?
IEC 62304 is an international standard that defines software development life cycle (SDLC) requirements for medical device software. It is applicable to medical device software functioning as a component of a medical device and to software that is itself a medical device. Although being compliant with IEC 62304 may not be required for your medical device, there are compelling reasons …
An assessment of your software should cover the mandatory process and documentation requirements for submitting your software to the FDA, but should also carefully inspect the design and implementation of the software to ensure that the software will function reliably in the field once released.
Cloud computing has become a pervasive technological evolution for building at-scale, distributed applications. Learn about the two main models used in distributed systems.