|
Software Development Life Cycle Services
|
|
Professional development of a commercial software product intended for a medical application, should be driven primarily by risk-management
and utilise structured quality processes compliant with industry regulations, that address software development; configuration management; problem
resolution and maintenance tasks and activities.
|
|
|
Whether the target product is a real-time embedded system, web-based application, or a stand-alone software system (SaMD) such as a mobile app used
as or with a medical device or in-vitro diagnostic device (IVD); C-Path applies software engineering analysis and design principles
and a structured risk-based approach to software development, compliant with IEC 62304, to produce quality solutions, appropriately
verified and validated with all supporting documentation necessary to meet current industry standards and regulations.
|
|
C-Path can provide consultancy and support in one or all phases of development including: |
-
Requirements Analysis: assistance with software requirements management - writing, developing and maintaining software requirements for your products;
-
Software Design: assistance with evaluating and documenting software architectures and detailed design specifications that meet
the regulatory standards and guidelines for pre-market regulatory review and post-market notified body or 3rd party audits;
-
Implementation: programming/coding for real-time embedded systems, stand-alone (SaMD) and web-based applications using a variety
of tools and techniques and designing and implementing graphical user interfaces;
-
Verification & Validation: documenting code reviews/walk-throughs, static and dynamic analysis; unit, integration and system-level software testing.
-
Maintenance: debugging; problem analysis, resolution, implementation and verification of design changes.
|
|
From a single day’s consultancy on a specific task or phase of development, to project
management of the entire development life cycle for a software product, C-Path
Software Engineering can help reduce the risks in getting your software to
market on time and to budget.
|
|