Advanced Manufacturing Solutions for Medical Devices
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
Deep Representation of Complex Manufacturing
Digitally model complex medical device production workflows, including multi-level assemblies, specialized processes, and validation requirements.
Irrefutable Electronic Controlled History Record (eCHR)
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.
Single Unified System
Real-time feedback between execution and planning ensures accurate schedules, optimized resource utilization, and rapid response to disruptions across multi-plant operations.
Unify Disparate Systems
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
Full Traceability and Genealogy:
Provides end-to-end traceability, documenting every stage of the production process, from design to finished product, ensuring all regulatory requirements are met.
Paperless Factory:
Automatic collection of electronic device history records (eDHR) provides an immutable audit trail of quality records on a foundation of blockchain technology.
Quality and Non-Conformance Management:
NCR and CAPA Management. Enforces robust quality processes and version controls, ensuring that products meet strict quality standards and regulatory guidelines.
Regulatory Compliance:
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.
Real-Time Monitoring:
Offers real-time oversight of production and quality metrics, enabling quick identification and resolution of any potential issues or defects.
Process Control:
Ensures consistent adherence to Current Good Manufacturing Practices (CGMPs) with enforced process controls, reducing the risk of non-compliance or product recalls.
Defect Detection and Prevention:
Identifies suspect materials and product defects early in the production cycle, preventing faulty products from reaching the market and ensuring patient safety.
Advanced Change Control:
Configurable approval process allows robust revision control where required but allows streamlined administration where changes do not impact quality.
Medical Device Resources
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Case Study
Implementing Advanced Plant Scheduling to Unlock Supply Chain Value
Learn how a global medical-device manufacturer cuts planning cycle times, improves schedule adherence, and drives higher productivity with optimized plant…
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Article
How to Tell Discrete from Process Manufacturing
The most important question “Can you take the manufactured product apart into its component parts?” The answer to this question…
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Article
Streamlining Product Validation and Manufacturing with a Modern MES
In today’s manufacturing world, adapting to production processes for new or updated products is never simple. Behind every successful product…
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Case Study
Case Study – Leading Med Dev Mfg Implements Advanced Plant Scheduling to Unlock SC Value
A leading global maker of medical devices had an ERP in place but did not have a formal plant planning…
