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White Paper Publications
Clients appreciate attention to detail and accurate execution. Explore these publications to help you learn about our processes.
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.
Is Your Software Project Meeting it’s
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?
Workflow Engine Technology
Maximizes Software Re-Use
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.
Benefits of Employing IEC 62304 for 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.
How Software Verification Streamlines
FDA Approval for Medical Devices
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.
Assessing Software Design and Software Quality for Medical Devices
An assessment of your software should cover the mandatory process and documentation requirements for submitting to the FDA, but should also carefully inspect the design and implementation of the software to ensure functional reliably in the field.