What This Product Solves

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Paper-based DHRs and manual review cycles
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Fully electronic, self-auditing eDHR and eBR generation
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Quality inspected after production instead of built into process
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Automated enforcement of operator, machine, material and process controls
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Limited visibility into nonconformance patterns and CAPA impact
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Structured event, nonconformance and root cause workflows
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Slow, manual product release and global change distribution
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Review-by-exception release and controlled global ECO enforcement

About Siemens Opcenter Execution Medical Device & Diagnostics

Within the Siemens Opcenter MOM offering, Opcenter Execution is a portfolio of industry and process-specific Manufacturing Execution Systems (MES) designed to enable organizations to monitor, control and manage all the activities, resources and work-in-progress (WIP) on the factory floor and across their enterprise during the execution of production.

Siemens Opcenter Execution Medical Device and Diagnostics (formerly known as Camstar Medical Device Suite) is a leading manufacturing execution solution for error-proofing processes, paperless manufacturing and electronic Device History Record (eDHR) management. It helps you accelerate innovation, reduce costs and deliver the highest quality products possible while making compliance a by-product of excellent manufacturing processes. Opcenter Execution Medical Device and Diagnostics (MDD) enables you to build and validate quality within the manufacturing process itself, instead of testing quality coming out of the process at every step. From raw materials to finished goods, Opcenter Execution MDD delivers a complete and self-auditing eDHR solution.

Opcenter Execution MDD automates and enforces complete control over the five “Ms” in Medical Device Manufacturing:

  1. Opcenter Execution MDD helps you manage Man: automatically checks training and certifications before allowing a user to work at an operation or inspection.
  2. Opcenter Execution MDD helps you manage Machine: ensures that only qualified equipment that is up-to-date on maintenance and calibration is used.
  3. Opcenter Execution MDD helps you manage Method: enforces process sequence, ensuring that all steps and data collection are complete and providing instant feedback to guarantee compliance.
  4. Opcenter Execution MDD helps you manage Material: ensures that operators use the right quantity of qualified materials, enforcing expiration dates, LIFO (Last In, First Out) and FIFO (First In, First Out) rules.
  5. Opcenter Execution MDD helps you manage Measurement: ensures that all required data is collected as compared to specification limits and automatically triggers rework or non-conformance workflows.

Opcenter Execution MDD was built integrating best practices in Medical Device Manufacturing, enabling faster out-of-the-box implementation. The software is highly functional and flexible, and provides an advanced and intuitive user experience. It also integrates fully with other enterprise systems, such as PLM, ERP, Production Planning & Scheduling and Manufacturing Intelligence (MI) platforms, helping you reap the benefits of true closed-loop manufacturing.

Outcomes we deliver

What You Get With IndX + Siemens Opcenter Execution Medical Device & Diagnostics

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Paperless, Self-Auditing Manufacturing
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Automated Process Enforcement
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Forward and Backward Traceability
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Event and Nonconformance Management
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SPC and Continuous Improvement Enablement

Benefits of Siemens Opcenter Execution Medical Device & Diagnostics

  • Eliminate paper travelers and generate complete electronic device and batch history records.
  • Ensure the correct operator, machine, material, and measurement are used at every step.
  • Identify at-risk materials quickly using configurable containment and where-used analysis.
  • Capture, escalate, and triage quality events in real time with structured workflows.
  • Apply statistical process control to detect variation while production continues.
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Why Siemens Opcenter Execution Medical Device & Diagnostics

This is not generic shop-floor software.Opcenter Execution Medical Device & Diagnostics is not generic shop-floor software — it’s an industry-specific solution built for regulated manufacturing environments.

Opcenter Execution Medical Device & Diagnostics

It combines built-in best practices with capabilities such as:

  • Error-proofed manufacturing processes and enforced sequencing
  • Electronic device history records (eDHR) and batch records
  • Automated nonconformance detection and notification
  • Multi-tier BOM and configuration enforcement
  • Role-based authorization with e-signatures
  • Full forward and backward genealogy
  • Integrated quality and manufacturing data with complete audit trails
  • Structured data collection to support Lean and Six Sigma

Designed for discrete, batch and combination-device manufacturing, it ensures compliance and quality-by-design at scale.

IndX helps manufacturers go beyond “paperless” by architecting the solution to fit any regulatory landscape, product complexity and global footprint, while enabling operational maturity, faster release cycles and continuous compliance.

Extend Your Digital Thread

Brandon Johnson

Director of Services – MES/MOM Pillar
Brandon is a business leader with 15+ years of experience building and leading IT consulting and system integration teams focused on Industry 4.0 and enterprise digital transformation in manufacturing. He has directly led $10M+ transformation programs and managed teams across large-scale IT application rollouts in pharmaceutical, medical device, food & beverage, and agroscience environments.
talk with our experts
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IndX Is a Certified Siemens Digital Industries Partner

IndX supports global medical device manufacturers with scalable, compliance-ready MES implementations:

  • Multi-site rollouts with global consistency
  • Validation-aligned implementation approaches
  • Secure, compliant architecture design
  • Integration across PLM, ERP, automation and intelligence

Medical device implementations fail when MES is treated as an IT project. IndX takes a different approach, bringing:

  • Deep Siemens MOM expertise
  • Proven experience in regulated-industry deployments
  • Global template and governance frameworks
  • Architecture-first validation support
  • Alignment across quality, engineering and operations

We don’t just deploy software, we operationalize compliance at scale.

Start Your Digital Thread With IndX

Fix execution at the source

When engineering, manufacturing, supply chain, and analytics run on disconnected data, problems compound downstream. IndX helps you establish a controlled digital thread that turns intent into reliable execution. Start with a free assessment call.
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