The battle for profitability and market share in the Medical Device and Diagnostics manufacturing industry grows ever more intense. Advancing product technology, intense regulatory pressure and pricing and margin pressure due to new reimbursement and purchasing practices are driving companies to seek new ways to become more efficient, speed innovation and decrease costs.


Many Medical Device and Diagnostics companies try to meet the exploding demand for customized and personalized products, high quality and lower price points by integrating a patchwork of paper, MS- Excel and legacy computer systems. Lack of a modern, common infrastructure to achieve complete paperless manufacturing hampers their ability to develop and produce products at the highest quality in a rapidly changing market.

Unlike other complex industries, MDM companies must comply with increasingly stringent regulatory standards with massive documentation requirements to ensure patient safety above all else. Paper and legacy systems make it impossible to create consistently accurate and error proof “as built” Device History Records (DHR’s).

Traceability encompasses inbound materials, production counts, assembly data and recorded quality data to meet regulatory requirements (US - 21 CFR Part 11, 820, EU Manufacturers - Directive 93/42/EEC on Medical Devices). Audits from regulators or quality audits from downstream supply chain partners become a business risk.

Medical Device and Diagnostics products are rapidly becoming smarter and more personalized to deliver better outcomes to patients. New products constantly enter the production pipeline, and spend less time before designs change or are discontinued. In some cases, lot sizes are reduced to one…the definition of mass customization. In order to provide operator work instructions, fabricate and assemble products, and collect and integrate quality data, companies can no longer avoid the need for a modern, integrated manufacturing system.

Speed, innovation, productivity & quality at lower cost

The ‘FDA Case for Quality’ initiative is shifting the focus for Medical Device industry from compliance driven to product quality driven. Critical Manufacturing’s MES for Medical Device and Diagnostics has been developed specifically for manufacturers to turn data into actionable knowledge that will prevent errors, increase efficiency and decrease the risk of regulatory action or recalls.

Industry 4.o scalable architecture

Built on a modern, modular architecture, Critical Manufacturing Medical Device MES™ is based on industry best practices and provides the flexibility and agility to ramp production and get products to market quickly while accurately recording manufacturing traceability and building quality into the process, eliminating the labor, support costs and errors of paper and legacy systems.

Solution Map

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»» Download Critical Manufacturing MES for Medical Device Brochure

Advanced modeling, deep medical device specific functionality

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 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.

Flexibility, agility and scalability

Maximum flexibility to design, model, deploy and monitor operations

Increased visibility to manage product flow within a company, or between companies in the supply chain

Easy equipment and device integration allowing electronic capture of quality data, including next generation IoT devices and sensors

Complete modular scalability for companies ranging from single site to global multi-site enterprise.

Unlimited device connectivity allows fully integrated manual and automated process steps, storing results as electronic product genealogy

Case Study:

MES for Medical Devices. Moving Faster from Development to Full Scale Production

This Case Study showcases the MES implementation at a US site of a top multinational company 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.


White Paper:

Quality is Everyone's Business. Outlining 10 reasons why the MES/MOM platform is the best for Manufacturing Quality Management.

This White Paper provides a foundation for the argument for why the best platform for implementing a quality system is the MES/MOM platform.