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Critical Manufacturing MES for Medical Devices

There is intense pressure on the Medical Devices Manufacturing industry to show growth and profitability by addressing topics of thin margins, rapid product innovations, quality driven products & stringent regulatory compliance. These issues can be addressed effectively with cost reductions and improved speed of innovation by  using the latest Industry 4.0 technologies in Manufacturing

Key Challenges of Medical Device and Diagnostics manufacturing industry addressed by CM MES V6

  • Paper Driven Manufacturing Operations – Labor intensive, Slower decision making
  • Legacy & Broken Systems- heavy maintenance, unplanned Downtime
  • End to End Traceability- Supplier to Customer product tracking
  • Quality & Regulatory Compliance- Continuously Changing
  • Innovations- Custom Products with shorter shelf life and small batches

Our Solution provides Agility, Innovation, Efficiency & Quality at Lower Cost

Key Capabilities for Industry 4.0 for Medical Devices Industry

  • Create fully automated, searchable and self-auditing electronic Device History Records or Batch records (eDHR/eBR) for rapid traceability and complete paperless manufacturing
  • Turn your documents into real-time actionable intelligence and shift from data to knowledge.
  • Enable plant modeling and increased visibility to allow companies across your supply chain to share information, ensure quality, comply with regulatory requirements, and reduce time to market.
  • Efficiently manage process and product changes, reduce variability, and ramp both yield and production at lower cost in a single solution.
  • Ensure closed-loop quality processes with workflows for CAPAs, NCRs and all SOPs.
  • Enforce operator certification and compliance in training requirements with electronic sign offs.
  • Achieve full traceability and a Plant 3D digital twin for real-time views of equipment location and status.
  • Boost flexibility to easily model lines for high-mix, low volume, frequent changeovers.
  • Speed up new product introduction by improving quality and yield in a way that’s visible to engineering, production and R&D.
  • Reduce the time and cost of system validation with a complete CSV Source Book.


Customers Testimonials

“Our manufacturing activity embraces combined  semiconductor, flat panel display and discrete manufacturing processes, so we wanted a solution that could track and report activity in all the different areas and present a full picture.” MES Project leader


“By moving to a “compliant system” we expect to be able to avoid paper based compliance processes. Not only can we redeploy people into more productive tasks, we will end up with a much more powerful solution because all the past historical production data will be available for interrogation and analysis in a single data warehouse – and not fragmented across a set of job specific manual compliance reports.” MES Project leader


“We are working in almost virgin territory with this product family so we have been developing the production process at the same time as we develop products. So solution flexibility and adaptability were very important attributes in our evaluation process.” “Many of us have worked with older proprietary systems in the past where solution specialists had to make changes to deliver the incremental functionality we needed. This introduces not only a continual source of frustration, but also a maintenance cost burden.” MES Project leader



“Meeting our compliance obligations proved to be much simpler with a completely new solution than one might imagine. We certainly had some work to do, but underpinning the solution is a standard platform that has already been rigorously tested in many other equally demanding and regulated industries” MES Lead

Read more about Industry 4.0 for Medical Devices Industry and about Critical Manufacturing Solutions.

CLICK HERE to download

Brochure - Industry 4.0 Medical Devices Industry