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.
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.
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
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
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.
Critical Manufacturing MES allows medical device manufacturers to not only comply with stringent regulations, but transform business results with effective predictive analysis to sustain continuous improvement initiatives and ensure high quality products. Critical Manufacturing's modern MES provides an agile, responsive, and fully integrated manufacturing data management system which provides full data context, integrating operational technology data and information technology data to provide feedback loops at different levels of the production.Download eBook
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.
Medical Device manufacturers that started on the path to digitization with Critical Manufacturing MES: