Medical Device Manufacturing

Medical Device and Diagnostics manufacturers face overwhelming challenges to bring the right products to market, at the right time, and most importantly, at the highest quality. Unlike other complex industries they have to also comply with increasingly stringent worldwide regulations, with massive documentation requirements to ensure patient safety above all else. Pricing and margin pressure from reimbursement and purchasing practices are further driving companies to seek new ways to become more efficient, speed innovation and decrease costs.

Manufacturers must now embrace digitalization to upgrade process capability, manage capacity, reduce cost and help shift their focus from managing compliance and risk to agility and product quality.

Accelerate NPI

Assure Quality

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. Speed time to market with Critical Manufacturing’s groundbreaking IoT Data Platform, an end to end solution that transforms connectivity to IoT and other data sources to reveal powerful new data insights. Data is enriched with MES contextual data to close the loop with decisive action. Apply machine Learning and other AI technologies to create predictive and prescriptive models to prevent errors, provide deep root cause analysis and transform business outcomes for today and the future. The new Factory Automation module is factory level workflow engine that helps manufacturers progressively increase their automation capabilities all the way to ‘Light Out’ smart factories.

Critical Manufacturing MES V8 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.

Ease Traceability and Regulatory Reporting

Boost Efficiency and Profitability

With Critical Manufacturing MES V8 manufacturers can achieve complete, error-proof paperless manufacturing across their operations. The risk of recall or regulatory action is eliminated with fully automated, fully searchable and self-auditing electronic DHRs/BRs. The comprehensive system delivers traceability across inbound materials, production counts, assembly data and recorded quality data to exceed 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.

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Traditionally, compliance and a lack of visibility across operations has hampered the productivity of medical device companies. Critical Manufacturing MES V8 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. The new Material Logistics manages the entire materials lifecycle for just-in-time manufacturing, ensuring product quality and profitable operations. The new Factory Automation module is factory level workflow engine that helps manufacturers progressively increase their automation capabilities to ensure reliability and repeatability of complex operations. To smooth the burden of validation, Critical Manufacturing provides a Validation Sourcebook that meets the requirements of the new FDA Computer System Assurance (CSA) approach.


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, boost innovation and decrease the risk of regulatory action or recalls. Critical Manufacturing MES V8 is packed with the latest technologies to drive digitalization initiatives faster and further with powerful manufacturing data insights and all the capabilities to gain the benefits from Industry 4.0-ready connected and knowledge intensive production.


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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. Critical Manufacturing MES V8 is modern, configurable and ready for new business models and technologies. Gain the benefits:

Inherent compliance, documentation and risk management based on comprehensive integrated functionality

Learn faster with deep understanding to transform business outcomes with the power of an Integrated IoT Platform and data science tools

Confidence to adopt an integrated software approach to reduce risk and move away from paper documentation to data-driven insights with available CSA validation

Agility to innovate and commercialize to respond to market, technology and regulatory changes with robust configuration and rollout capabilities for validated processes