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.
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Development
- ISO 62304 SDLC Processes
- Software as a medical device
- Embedded Software
- Clinical Decision Software
- QMS/Non-product Software
- Manufacturing software
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Compliance
- UKCA - UK MDR
- EU CE - MDR/IVDR
- FDA 510(k)/PMA/De Novo/CLIA
- Technical Files/Design Dossiers
- ISO 14971 Risk Management
- GAMP 5/Software Validation
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Quality
- ISO 13485/MDSAP/ISO 9001
- QMS Implementation
- Risk Management
- Audits
- Support
- Training
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Security
- 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.