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.

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
elekta_logo_big

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
Craig Pinegar Profile_282x376px_4

We wanted a strategic MES partner rather than a software vendor, and we have found such a partnership in Critical Manufacturing. Beyond their help with MES implementation, we take a very active part in shaping their future product roadmap for the Medical Device community.

Craig Pinegar Director of Manufacturing IT at Ultradent Products Inc.

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

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Affordable MES

Performance and scalability for time-critical industry environments

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8 Reasons Why Manufacturing IIoT Projects Fail

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automated validation white paper
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Automated Validation

The next generation approach to accelerate MES implementations

Digital Twin and Augmented Reality
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Digital Twin and Augmented Reality

From ideal to real with MES

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Medtech Must Embrace Industry 4.0 to Thrive in the Economy

Axendia White Paper presented by Critical Manufacturing

Case study MES for Medical Devices. Moving Faster from Development to Full Scale Production-preview
Case Study
MES for Medical Devices: Moving Faster from Development to Full Scale Production

MES implementation at leading international Medical Device company

Accelerate progress towards Industry 4.0

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