Medizintechnik

As aging populations and the expansion of the global marketplace fuel demand, an increasingly stringent regulatory environment complicates product delivery for medical device manufacturers.

Challenge:

Medical Device Manufacturing

Medical Device manufacturers are beset with exploding demand for customization and quality. They need to manage thousands of data point efficiently and meet stringent compliance requirements.

To be successful, these companies must find ways to meet both customer and regulatory demands without sacrificing the efficiency and throughput that make them profitable.

Benefits:

cmNavigo MES provides a flexible system tailored to 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.

Capture highly granular historic and process data,

Enforce training requirements, sign offs and data validity checks,

Schedule calibrations and other maintenance activities,

Set up advanced reporting, analytics, role-specific workflows and action plans.

Result:

Our manufacturing execution and intelligence platform provides the greatest agility and scalability, enabling 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 yield, cycle time and equipment utilization with an integrated, one-stop shop for demanding medical device requirements

Visibility: Model a range of environments for real-time decision making and long-term process improvements

Reliability: Improve automation, control and traceability, meeting the highest customer quality standards and ensuring proper support for compliance to Titles 21 CFR Part 11 and 820


For more information please download the Medical Devices brochure


White paper

Quality is everyone's business:
Outlining 10
reasons why the MES/MOM platform is the best for Manufacturing Quality Management.

By Francisco Almada Lobo, CEO and co-founder, Critical Manufacturing

This article will provide a foundation for the argument for why the best platform for implementing a quality system is the manufacturing execution system or manufacturing operations management (MES/MOM) platform.

The following aspects are considered:

  • information flow
  • master data
  • electronic device history records
  • manufacturing document control
  • single source of truth for reporting and analysis
  • process control
  • regulatory compliance
  • equipment management
  • integrated CAPA
Download