Overview

Knowllence's Medical Device Software is a comprehensive solution designed to assist medical device manufacturers in managing risk and ensuring compliance with international standards such as ISO 14971 and IEC 62366. The software offers modular tools that facilitate the integration of customer requirements, functional analysis, and risk management into the design and development process of medical devices. By centralizing data and processes, it enhances collaboration between regulatory affairs and design teams, ensuring consistency and traceability throughout the product lifecycle.

Features and Capabilities

• Modular Architecture: Includes modules like RM 14971 for risk management, Need for capturing customer requirements, Structure for cross-referencing needs with technical specifications, and FMEA for conducting Design and Process Failure Mode and Effects Analyses.
• Risk Management Compliance: Aligns with ISO 14971:2019, facilitating hazard identification, risk evaluation, and control measures throughout the device's lifecycle.
• Usability Engineering: Supports compliance with IEC 62366 by integrating usability considerations into the design process.
• Data Consistency and Traceability: Ensures coherence between usability test reports and risk management documentation, aiding in audit preparedness.
• Time Efficiency: Automates report generation and version management, reducing manual efforts and accelerating updates.
• Customization and Flexibility: Offers pre-integrated content libraries that can be tailored to include specific hazards, occurrences, and harm scenarios relevant to the organization.
• Multilingual Support: Accommodates multiple languages for both interface and documentation, catering to global teams.
• Collaboration Tools: Facilitates teamwork through graphic visualization and workflow management tools, enhancing communication among stakeholders.
• Audit Readiness: Maintains up-to-date and standardized documents, ensuring readiness for regulatory inspections.
• Integration with Quality Management Systems: Can be incorporated into existing QMS frameworks, supporting standards like ISO 13485 and FDA 21 CFR Part 820.