Medical Device Manufacturing
Medical device and diagnostics manufacturers must continue to introduce new products using specialized product technology, all the while complying with ever-shifting worldwide regulations. Pricing and margin pressure from reimbursement and purchasing practices are driving companies to seek new ways to become more efficient, speed innovation and decrease costs. With the European Union’s Medical Device Regulations (MDR) taking effect, and the FDA’s cybersecurity and shift from QSR to ISO 13485 and ISO regulations, companies must do all of this within stricter guidelines.
Critical Manufacturing Augmented MES helps Medical Device manufacturers constantly upgrade process capability and manage capacity and quality, while driving down cost.
Innovation is leading to larger medical device portfolios and a large number of smart and personalized products to deliver better outcomes to patients. With this constant flow of new products and configurations coming into production, manual systems risk quality and compliance problems.
Critical Manufacturing MES for Medical Device is comprehensive to manage all aspects of production, quality and documentation. It integrates to systems for development, procurement, and materials management. It can model frequent changeover lines for maximum throughput and quality. Experiments Management also supports rapid process improvement by integrating design of experiments (DoE) with execution of them.
Augmented MES has a full suite of fully integrated Quality Management capabilities, which ensure an error-proof production process. All production processes and steps are enforced and closed-loop NCR and CAPA processes prevent issues from reoccurring. This approach means both better quality outcomes and the complete automation of documentation. Connect IoT flows data from equipment and IoT intelligent sensors for process-level assurance. Further, Critical Manufacturing MES incorporates Augmented Reality, guiding operators interactively through detailed product and process steps, work instructions, schematics, materials and tool selection to complete tasks efficiently, error-free and hand-free. Combination device makers can use Weigh and Dispense to ensure precise, safe and consistent recipe based product quality.
It can be complex to create consistently accurate and error proof “as built” Device History Records (DHRs). In Augmented MES, DHRs are automated, fully searchable and self-auditing. This comprehensive system delivers traceability across inbound materials, production counts, assembly data and recorded quality data to meet regulatory requirements such as FDA 21 CFR Parts 11 and 820 and EU Directive 93/42/EEC on Medical Devices. The MES includes all e-signatures and operator certification in line with the process. Reporting for audits is easy to assemble and slice by time, product group, materials, operator or any other factor.
Traditionally, compliance and a lack of visibility across the operation has hampered the productivity of medical device companies. Augmented MES enables plant modeling and increased visibility to allow companies across your supply chain to share information, ensure quality, comply with regulatory requirements, and reduce time to market. BI Cards and a Digital Twin enable real-time views of performance. Critical Manufacturing provides a CSV Sourcebook to speed validation of enhanced processes. When a validated process change is approved, Change Management can ensure it rolls into production as intended.
Augmented MES for Medical Device
Medical device companies must aggressively broaden their focus from compliance to product quality. Critical Manufacturing’s MES for Medical Device and Diagnostics has been developed specifically for manufacturers to turn data into actionable intelligence that will prevent errors, increase efficiency and decrease the risk of regulatory action or recalls.
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Seize the benefits on your shop floor
Many medical device manufacturers work with a patchwork of paper, spreadsheet, and point applications. A modern comprehensive Augmented MES can deliver so many more benefits:
Inherent compliance, documentation and risk management based on comprehensive integrated functionality
Visibility and deep understanding from clear user-configurable GUIs with modern analytics behind them
Confidence to adopt an integrated software approach to reduce risk and move away from paper documentation to data-driven with an CSV experienced team’s support
Agility to innovate and commercialize to respond to market, technology and regulatory changes with robust configuration and rollout capabilities for validated processes