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.
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.
A deep representation of complex manufacturing requirements allows our application suite to deliver real-time feedback across single-plant and multi-plant operations. By connecting to existing transactional systems and devices, this creates event-based workflows while also embracing and extending your in-house AI LLM applications.
End-to-end label lifecycle management built into the Eyelit MES, from design approval and e-signature release through print verification, reconciliation, and eDHR capture. Full compliance with FDA 21 CFR Part 830, Part 11, and ISO 13485 label control requirements, without dependency on disconnected external systems.
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.
Enforces end-to-end label governance – approval workflows, operator verification, and print reconciliation – ensuring only compliant, approved labels reach the production floor and every label event is captured in the eDHR.
Captures true labor effectiveness in real time, turning hidden productivity losses into targeted, actionable fixes.
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