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Software Quality Management
Good software engineering practice includes effective quality assurance and control integrated into any software development project. A formal means of controlling software activities and tasks including documentation; source code; maintaining records; reporting incidents; problem resolution and verifying important processes, (including software risk management, development and maintenance), supports regulatory compliance requirements in all regions of the world.
C-Path Software Engineering has experience in the implementation, use and compliance of medical industry standards including: ISO13485; ISO14971; ISO 62304; ISO 60601; FDA CFR Parts 820, 801. We can help your company plan and implement a quality management system designed for the manufacture of products containing software (or stand-alone software systems); ensuring your software quality processes and procedures are compliant with recognised industry standards.
C-Path can provide assistance with continuous improvement to existing quality systems and provide independent internal (ISO 13485 Lead Auditor) audit services; highlight any areas that might require attention, providing you with confidence of the readiness of your product for notified body audits and regulatory pre-market approval.
We offer a complete support service for medical software development and in addition to design and coding, we can assist in: Planning , implementation and documentation of Quality Management Systems and Processes; Generation of Technical Files/Dossiers Generation of Design History Files; Generation of Regulatory Submission files. We can work both comfortably using our own internal processes that can be mapped and comply with your QMS, or adapt to your quality management system and adhere to your internal processes and procedures.
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