Medical Device Manufacturing

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.