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.

Development

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

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

Quality

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

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.