As aging populations and the expansion of the global marketplace fuel demand, an increasingly stringent regulatory environment complicates product delivery for medical device manufacturers.
Medical Device manufacturers are beset with exploding demand for customization, quality and price points to serve emerging markets. They need to manage thousands of data points efficiently to do all of that and meet stringent compliance requirements.
To be successful, these companies must find ways to meet patient, practitioner, payer and regulatory demands without sacrificing the efficiency and throughput that make them profitable.
Critical Manufacturing MES is a flexible system for the Medical Device segment that enables you to model and manage production environments from the simplest to the most complex and improve visibility into the factors that impact production decisions.
|Ensure and enforce quality system processes with workflows for CAPAs, NCRs and all SOPs|
|Capture highly granular historic and process data|
|Enforce compliance in training requirements, electronic sign offs for 21 CFR part 11, and data validity checks|
|Schedule calibrations and other maintenance activities|
|Set up advanced reporting, analytics, role-specific workflows and action plans|
Our manufacturing execution and intelligence platform provides the greatest assurance of regulatory compliance combined with agility and scalability. This enables you to lower overall TCO while improving online visibility and operational intelligence, with a complete set of easily configurable and smoothly integrated modules fulfilling the most challenging Agility, Visibility and Reliability requirements.
Agility: Improve quality, cycle time and equipment utilization with an integrated, one-stop shop for demanding medical device requirements
Visibility: Model a range of environments from pure discrete to combination products for real-time decision making and long-term process improvements
Reliability: Improve automation, control and traceability, meeting the highest regulatory and customer quality standards and ensuring proper support for compliance ISO, FDA and other regulations such as 21 CFR Part 11 and 820, ICH Q8-12, and others
For more information please download the Medical Devices brochure