The Medical Device Industry product characteristics include cost sensitive mass market products, complex high value products, and specialty items that are engineered and configured for a specific patient. Each of these business segments needs to operate in a highly regulated environment that requires very detailed and accurate compliance tracking (ISO13485, EU MDR 2017/745, and FDA 21 CFR Part 820 and Part 11).
First and foremost is ensuring regulatory compliance, which can increase the supply chain challenges of achieving high on-time delivery, low costs, right sized inventory levels, high asset utilization, and high productivity. The Eyelit solution suite, Eyelit SIOP, Eyelit APS, and Eyelit MES, addresses these challenges with a unified digital solution that combines Planning, Scheduling, and Execution powered by AI and optimization.
Differentiating Capabilities
Eyelit Technologies enables manufacturers to digitally model complex medical device production workflows, including multi-level assemblies, specialized processes, and validation requirements. Manufacturers gain real-time visibility into operations, enforce standardized procedures, and drive continuous improvement across labor, equipment, and quality performance.
A configured subset of production data is automatically captured and stored in a secure, immutable electronic controlled history record (or electronic device history record eDHR)), creating a lifetime digital record of each manufactured product. Blockchain-supported records and compliant electronic signatures ensure audit readiness and regulatory traceability.
Real-time feedback between execution and planning ensures accurate schedules, optimized resource utilization, and rapid response to disruptions across multi-plant operations.
Connect to existing transactional systems and devices to provide event-based workflow but also embrace and extend your in-house AI LLM applications by allowing them to interoperate with our value-added small language purpose-built AI models.
Key capabilities
Provides end-to-end traceability, documenting every stage of the production process, from design to finished product, ensuring all regulatory requirements are met.
Automatic collection of electronic device history records (eDHR) provides an immutable audit trail of quality records on a foundation of blockchain technology.
NCR and CAPA Management. Enforces robust quality processes and version controls, ensuring that products meet strict quality standards and regulatory guidelines.
Helping manufacturers adhere to FDA regulations and ISO standards, ensuring compliance with ISO13485, EU MDR 2017/745, and FDA 21 CFR Part 820 and Part 11 for electronic records and signatures.
Offers real-time oversight of production and quality metrics, enabling quick identification and resolution of any potential issues or defects.
Ensures consistent adherence to Current Good Manufacturing Practices (CGMPs) with enforced process controls, reducing the risk of non-compliance or product recalls.
Identifies suspect materials and product defects early in the production cycle, preventing faulty products from reaching the market and ensuring patient safety.
Configurable approval process allows robust revision control where required but allows streamlined administration where changes do not impact quality.
Implementing Advanced Plant Scheduling to Unlock Supply Chain Value
Unlocking Value:
Learn how a global medical-device manufacturer cuts planning cycle times, improves schedule adherence, and drives higher productivity with optimized plant scheduling.
Going Electronic Without Losing Control: eDHR Done Right
Going electronic in a regulatory world – do I take the plunge? It’s a common dilemma that manufacturers who must comply with stringent medical regulations (such as FDA 21 CFR Part 820 and 21 CFR Part 11 in the US, EU MDR 2017/745, ISO 13485, and associated GxP requirements) will always have. I want to get rid of paper, but is it worth the risk and the effort, and how do I reduce the risk? How do I persuade my quality department that this is a risk worth taking?
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