Design Control Software

Overview

SimplerQMS offers a comprehensive Design Control Software that integrates into an all-in-one eQMS, specifically tailored for medical device manufacturers. This solution is designed to ensure optimal device performance and minimize risks, facilitating compliance with regulatory standards.

Key Features

• Centralized Document Management: Organize all necessary design and development documentation including Technical Files, Device History Records, Design History Files, and Device Master Records in a cloud-based system.
• Compliance and Audit Support: Utilize dashboards and search tools to streamline audit processes and handle submissions such as EU MDR or 510(k). Export documents securely for partners and audit purposes.
• Regulatory Compliance: Achieve compliance with regulatory bodies like EU MDR, IVDR, and FDA standards including 21 CFR and ISO norms. The system supports out-of-the-box compliance without additional validation efforts.
• Effective Collaboration: Facilitate document sharing with partners, suppliers, and auditors. Use metadata to tailor access and efficiently communicate updates.
• Risk Management Integration: Link risk assessment to design documents to preemptively tackle potential issues and comply with standards like ISO 14971:2019 and ISO 13485:2016.
• Change Tracking and Training: Record changes with time-stamped audit trails and maintain up-to-date documentation. Enhance team competencies through integrated training management capabilities.

Benefits

This software offers a reliable, secure cloud-based system compliant with ISO 27001:2022 for document storage, leveraging Microsoft Azure Data Centers. All changes and document versions are meticulously tracked, ensuring traceability and up-to-date compliance. The integration capabilities with other applications through APIs facilitate seamless operation, enhancing overall workflow efficiency for medical device manufacturers.

With its user-friendly interface, the platform allows for efficient organization of documents for regulatory submissions, better handling of risk assessments, and optimization of device design processes. This comprehensive solution ensures that your design documentation is thorough, well-managed, and easily accessible, thus reducing time-to-market and improving operational effectiveness.