Welcome to C-Path Software Engineering Ltd
Professional software consultancy services for start-up and small to medium enterprises. Our focus and expertise is medical device software engineering; regulatory compliance; 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; ensuring the correct documentation, compliance evidence and data required for successful market approval and release.
Development
- ISO 62304 SDLC Processes
- ISO 14971 Risk Management
- SaMD/AIaMD
- SiMD/Clinical Decision Software
- QMS/Non-product Software
- Manufacturing software
Compliance
- Pre-market Approvals/Changes
- UKCA - UK MDR
- EU CE - MDR/IVDR
- FDA 510(k)/PMA/De Novo/CLIA
- Technical Files/Design Dossiers
- GAMP 5/Software Validation
Quality
- QMS Implementation
- Quality Management/Assurance
- ISO 13485/MDSAP/ISO 9001
- Audits
- Training
- Support
Security
- ISMS Implementation
- ISO 27001/ISO 27002
- 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.