Medical Devices

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 Manufacturing

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

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

Case Study:

MES allows medical device manufacturer to increase compliance, efficiency and control

by Critical Manufacturing

The MES implementation in this case study was deployed at a US site of a top multinational company initially developing product and processes for fabricating complex imaging devices, with the intent that it would also support their move from development to full scale production.

Fill out the form below to download the document.