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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.
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