Welcome to C-Path Software Engineering Ltd

Professional software consultancy services for start-up and small to medium enterprises. We provide expertise in software development; regulatory compliance, risk management; quality and information security management and computer system validation/software assurance. With a background in Aerospace software engineering and active in software development since the early 1990s, C-Path have experience with a wide range of software and applications for medical devices/IVDs and can provide you with support, advice, training and assistance in medical device product development and the necessary documentation, evidence and data required for successful market approval and release.


  • ISO 62304 SDLC Processes
  • Software as a medical device
  • Embedded Software
  • Clinical Decision Software
  • QMS/Non-product Software
  • Manufacturing software


  • FDA 510(k)/PMA/De Novo/CLIA
  • Technical Files/Design Dossiers
  • ISO 14971 Risk Management
  • GAMP 5/Software Validation


  • ISO 13485/MDSAP/ISO 9001
  • QMS Implementation
  • Risk Management
  • Audits
  • Support
  • Training


  • ISO 27001/ISO 27002
  • ISMS Implementation
  • Security Risk Management
  • ISMS Audits
  • Medical Device Cybersecurity
  • Training

Whether you require support in getting your software to new markets for the first time; assistance with industry regulations, standards and guidance; implementation of management system processes and procedures; or validation of software in your manufacturing processes or quality system; we have the necessary skills and flexibility to meet your project requirements - from a single day's consultancy focused on a particular task or development phase, to management and implementation of a large-scale development program.