Software Quality
Crucial software oversight, from simple audits and guidance to fully managing the process. Our team creates any deliverables needed for software quality compliance, excepting unit code-test that are typically addressed by the programmers.
We follow standard, best practice, and FDA guidances to generate the IEC 62304-compliant documentation necessary for 510(k), PMA, and Electrical Product Safety tests, and are flexible with the templates you want to use.
Software Requirements Specification
Software Detailed Design
Software Test Plan
Software Test Protocols
Software Test Reports
Software Summary Test Report
Software Standard Operating Procedure (SOP) Development
IEC 62304:2006 / Amd 1:2015
IEC 60601-1:2005 Clause 14
Programmable Electrical Medical Systems (PEMS)
Software Development Plan
Software Architecture Design
Additional Services
Electrical Engineering
Requirements drafting, schematic capture, board layout, and production of prototypes.
Risk Management
Aiding your risk management planning and analyses to support new or existing products.
Usability
Creating your usability documents, executing the appropriate testing and obtaining certifications.