Medical Device Manufacturing

Embrace digitalization - shift your focus from managing compliance and risk to agility and product quality.

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Medical Device Manufacturing

Embrace digitalization - shift your focus from managing compliance and risk to agility and product quality.

Download Brochure

Driving digital transformation for Medical Device manufacturers

Critical Manufacturing’s MES for Medical Device and Diagnostics is a unified application packed with the latest technologies to drive digitalization initiatives faster and further to gain the benefits from Industry 4.0. It helps to drive control, resilience, collaboration and agility across the entire production process, from raw materials to the patient.

Overcome the key challenges of ahighly regulated industry

Medical Device and Diagnostics manufacturers face overwhelming challenges to bring the right products to market, at the right time, and at the highest quality. Critical Manufacturing’s modular solution will enable you to:

As Medical Device manufacturers digitalize operations, the increasing levels of intelligence built into sensors, devices and equipment can generate staggering amounts of valuable data. Critical Manufacturing’s new IoT Data Platform transforms connectivity to IoT and other data sources to reveal powerful new data insights. Identify the true root causes of problems faster and improve the speed of learning to improve yields, and reduce the ramp up time of new technologies, equipment, processes, materials and products. Apply machine Learning and other AI technologies to create predictive and prescriptive models to transform quality.

Fully integrated Quality Management capabilities ensure an error-proof production process with closed-loop NCR and CAPA processes that prevent issues from reoccurring. Document Management makes sure that only the most up-to-date documents are used and Statistical Process Control (SPC) automatically reacts to errors and takes decisive action. Manufacturers with formulation processes can use Weigh and Dispense to ensure precise, safe and consistent recipe based product quality. Improve supplier quality with fully configurable Sampling plans including Acceptable Quality Levels (AQL) and reduce the risk of human error making sure that manufacturing operators are trained and certified.

Achieve the highest quality outcomes with the complete digitalization of production and quality documentation with fully searchable and self-auditing electronic DHRs/BRs. Material traceability and genealogy is provided at the individual batch, lot, or unit level, meeting full compliance with the latest EU Medical Device Regulation (MDR) requirements and Unique Device Identifier (UDI) tracking.
The comprehensive system exceeds regulatory requirements such as FDA 21 CFR Parts 11 and 820. Reporting for audits is easy to assemble and in the event of regulatory action or recall, the system enables rapid and precise identification of finished goods to minimize negative impact.

Critical Manufacturing MES enables plant modeling and increased visibility to allow companies across the supply chain to collaborate to boost agility. A factory Digital Twin module enables real-time views of shop floor performance. The Material Logistics module manages the entire materials lifecycle for just-in-time manufacturing. Connect IoT provides seamless connectivity with any type of equipment, performing automated data collection and equipment control. Factory Automation, a factory level workflow engine further helps manufacturers to progressively increase their automation capabilities, including control of autonomous transport systems. Augmented Reality guides operators interactively through detailed product and process steps to complete tasks efficiently, error-free and hand-free.

Next generation MES capabilitiesfor Medical Device Industry

Critical Manufacturing MES ensures a modular, yet fully integrated management of shop-floor resources.  The 40+ product capabilities provided by more than 20 modules are fully interoperable and give you real-time visibility and control across global manufacturing operations.

TIP: Click on the selected modules for more information.

icon_manufacturing_operations Manufacturing Operations
Materials & Containers
Resource Tracking
Routing & Dispatching
Data Collection
Master Data Management and Change Control
Tasks, Checklists & e-signs
icon_visibility_and_intelligence Visibility & Intelligence
BI Cards
eDHR / Genealogy / Reporting
fabLIVE: Factory Digital Twin
Alarm Management
Augmented Reality
icon_quality_management Quality Management
Sampling Based Inspection / AQL
Statistical Process Control (SPC)
Document Management
Experiment Management
Operational Efficiency
Maintenance Management
Order Management
Labor Management
Advanced Layout & Printing
Material Logistics
icon_automation_and_integration Integration & Automation
Enterprise Integration
Equipment Integration: Connect IoT
Recipe Management
Weigh & Dispense
Factory Automation
Paul Straeten Profile_230x306px_1

If you look at the MES market as a whole, there are many established companies, but there are just a handful of players specifically for medical devices. We required a system that was rich and easy to use that we could confidently hand over to the engineers and end users. For reporting we did not want to invest in a whole new platform that has to be integrated and connected. That is why we looked at Critical Manufacturing.

Paul Straeten Head of Industry 4.0 and Advanced Analytics for the AIP Network at Medtronic
Mark Kaak profile photo

This is the start of a new future for Elekta. The payback on the MES is already coming from cost savings, increased efficiency, and easier compliance. We also benefit from freeing up resources to enable our business to innovate more and greater agility to respond to our customers’ demands.

Mark Kaak Elekta’s VP Global Manufacturing

Next generation Automated Validation

Critical Manufacturing’s next generation approach to validation goes beyond FDA’s guidance for Computer Software Assurance (CSA) to ensure a smooth validation process that maintains end-to-end traceability and can be executed automatically at any time, in parallel to implementation. This new approach substantially reduces the cost and burden of traditional approaches and speeds the implementation of Critical Manufacturing MES by reducing the timeline of the validation phase from months to days.

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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 is modern, configurable and ready for new business models and technologies.

Error-proof management

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

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Transformative insights

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

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Risk avoidance

Confidence to adopt an integrated software approach to reduce risk and move away from manual processes to data-driven insights with available automated CSA validation.

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Competitive advantage

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

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Factory-wide connectivity

Connect and manage different equipment throughout the shop floor, optimizing process flows and user actions through integrated workflows.

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Complete control over assembly process

Add schematics and diagrams to improve processes, record defects and other useful information.

Insights for transformational leaders in manufacturing

Automated Validation Video

Reduce the validation of MES implementations from month to days.

Cost of quality in MedTech

This article addresses the cost of quality in the industry and the role played by the MES platform in helping reduce these costs.

Press Release
Critical Manufacturing and Dataworks Partner to Take Regulated Industries into a New Era of System Validation

Why are MedTech manufacturers looking for cloud-based solutions?

The benefits of having a cloud-based MES include reduced HW and SW infrastructure cost, automation of validation activities, and better change control preventing re-validation efforts.

Critical Manufacturing V9 video_thumbnail
Master Manufacturing in Extreme Uncertainty with Critical Manufacturing MES V9

Master Manufacturing in Extreme Uncertainty with Critical Manufacturing MES V9

New customer announcement- Integer
Press Release
Integer Adopts Critical Manufacturing MES for Medical Device Manufacturing

case study_Elekta-Radiating Manufacturing Data for a Healthy Business - Preview
Case Study
Radiating Manufacturing Data for a Healthy Business

How the modern MES helps Elekta grow

Press Release BBraun
Press Release
B. Braun selects Critical Manufacturing MES as the global standard for Discrete Manufacturing

automated validation white paper
White Paper
Automated Validation

The next generation approach to accelerate MES implementations

Predictive quality
Electronic Device History Record

Real-time enterprise-wide visualization and monitoring

Case study Ultradent keyvisual
Case Study
A Step to the Future of Manufacturing

MES to Manage Extreme Vertical Integration at Ultradent Products Inc.

Accelerate progress towards Industry 4.0

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