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Welcome to C-Path Software Engineering Ltd
C-Path provides professional software consultancy services for start-up and small to medium enterprises seeking not only high-quality software engineering solutions for their medical products and associated applications, but expertise in medical device software quality and regulatory compliance, risk management, industry standards and guidance in order to support product design and development; transfer to manufacture; regulatory approval in UK, EU and Worldwide markets and subsequent post-market product development/software maintenance.
C-Path has the necessary expertise and experience to fully support and implement all phases of the software development life-cycle, from concept to market whilst ensuring compliance with the necessary quality processes (ISO 13485), standards (inc. IEC 62304; IEC60601; ISO 14971) and regulations is maintained throughout.
We have the flexibility to meet your development project requirements, from a single day's consultancy focused on a particular task or development phase, to management and implementaion of a large-scale development program.
In addition, C-Path has extensive knowledge and experience in the regulatory approvals processes for software in UK and worldwide markets including Europe (MDR/IVDR), USA (FDA QSR) and can provide advice, support, training and assistance in generating the necessary documentation and data required for a successful pre-market approval.
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