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Is your Software Project Meeting its Regulatory Requirements?

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?


Benefits of Employing IEC 62304 for Software Development of Your Medical Device

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 …


Assessing Software Design and Software Quality for Medical Devices

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, IaaS and PaaS

Cloud computing has become a pervasive technological evolution for building at-scale, distributed applications. Learn about the two main models used in distributed systems.