One of the tool that a Medical Device company should have when they want to optimize their Quality Management System and keep track of any regulatory activity, is their eQMS.
S-Cube Technologies with its experience in Quality and Regulatory Affairs has proved to know how to keep your company compliant. It has developed an electronic Quality Management System (eQMS) called SmartEye which will guide you to success with its workflows that are already configured to follow all the medical devices standards.
Check below the different features that this solution can provide to your company. And don’t hesitate to ask for a demo.
Transforming Medical Compliance
S-Cube Technologies, with their cutting-edge SmartEye eQMS, is spearheading a transformation in medical device manufacturing. This eQMS stands out for its ability to convert manual and paper-based processes into a streamlined digital platform, mitigating risk, accelerating compliance, and improving quality (https://smart-eye.io)
Expertise and Innovation
The team behind SmartEye boasts extensive experience in the medical device and healthcare sectors, driving innovation and delivering impactful products
Cloud-Based Security and Accessibility
SmartEye’s software is securely hosted on Azure Web Services, a trusted platform for many Fortune 100 companies. This ensures robust data storage, disaster recovery, and security, addressing the critical concern of data safety in the cloud
Comprehensive Regulatory Compliance
SmartEye is designed to facilitate compliance with quality and regulatory standards. It features Part 11 compliant workflows, e-signatures, and is integrated with ISO 14971 Risk Management standards, ensuring compliance with both 21 CFR Part 820 and ISO 13485:2016
Ready-to-Use Templates and Customization
The platform offers ready-to-use templates for various standards, including ISO 13485 and FDA Design Control, with the option to blend these with custom templates. This flexibility aids in creating audit-ready documents seamlessly
Global Collaboration and Integration
SmartEye supports global team collaboration, offering co-authoring, reviewing, and approving functionalities. This makes it ideal for teams spread across different geographical locations, enhancing workflow efficiency.
Seamless Data Migration
For organizations transitioning to SmartEye, the platform offers various methods to migrate existing QMS documents and data, with support during the onboarding process to ensure a smooth transition
International Application and Scalability
SmartEye is designed for global use, supporting medical device companies in navigating regulatory pathways and quality system requirements across different continents. This international reach is crucial for companies aiming to scale their operations without being hindered by quality system bottlenecks
Licensing and Accessibility
The software is available through a cloud-based subscription, accessible via standard web browsers. This approach aligns with modern CRM and ERP platforms, offering flexibility and ease of use
Customer-Centric Onboarding and Support
Onboarding with SmartEye is tailored to each customer’s primary focus area, typically ranging from two to four weeks. Additionally, customers receive dedicated support from medical device industry experts, ensuring a comprehensive understanding and utilization of the platform
Continuous Improvements Without Additional Costs
SmartEye is a cloud-based solution that regularly releases enhancements and features, specifically catering to the needs of medical device companies. Importantly, these upgrades come at no additional cost, removing the burden of system validation for users. The platform provides 21 CFR Part 11 compliant IQ protocol/checklist and completed OQ and PQ reports, further easing the compliance process
SmartEye by S-Cube Technologies emerges as a revolutionary tool in medical device manufacturing, offering a comprehensive, secure, and adaptable eQMS. Its blend of innovative features, expert support, and global applicability positions it as a pivotal solution for manufacturers seeking to navigate the complex landscape of global compliance and quality management.