MES & eDHR for Medical Device and Diagnostics Manufacturers
Accelerate innovation, reduce cost and achieve the highest product quality, while making compliance a by-product of excellent manufacturing.
Paperless, error-proof manufacturing with eDHR
Siemens Opcenter Execution Medical Device and Diagnostics (formerly “Camstar Medical Device Suite”) is a leading manufacturing execution solution for error-proofing processes, paperless manufacturing, electronic device history records (eDHR) and electronic batch records (eBR).
Emerging, midsize and global companies must balance cost reduction and regulatory compliance while consistently producing high-quality products. Conseptis helps medical device and diagnostics manufacturers implement, upgrade and maintain Opcenter so they can meet these challenges.
Opcenter Medical Device & Diagnostics services across the lifecycle
Implementation, upgrades and maintenance from one specialist team.
Implementation
New Siemens Opcenter deployments, from process modeling and configuration to integration, validation and go-live.
Learn moreUpgrade & migration
Move from legacy Camstar or older Opcenter releases to a supported platform, without disrupting production.
Read the upgrade guideMaintenance & support
Keep your production MES stable and compliant with incident resolution, fixes, enhancements and monitoring.
Learn moreImplementation of MES
Maximize profitability, flexibility, quality and compliance by digitally managing the rules and information for all operations and plant events in real time.
Error-proof production
We connect information technology with operational technology from your existing equipment and systems, so you can make data-driven decisions and automate more.
Analytics & predictive maintenance
Use sensor and system data from MES and IoT platforms for a complete view of operations, with quality control at every point in the product lifecycle.
Built for regulated medical device production
What Opcenter Medical Device and Diagnostics delivers on the shop floor.
Electronic data collection
Capture measurements, test results and inspection data directly into the eDHR, with limits enforced at entry.
Enforced routing
Operators only see the next valid step for each serial number or lot, so nothing is skipped.
Work instructions
Show the current, approved revision of every instruction at the workstation.
Training checks
Block steps an operator is not trained or certified for, with a full record of who did what.
Calibration & maintenance
Prevent use of equipment that is out of calibration or overdue for maintenance.
Material verification
Scan and verify components and lots at each step to prevent mix-ups.
Production scheduling
Sequence work orders by priority, due date and resource availability.
Yield analytics
Track throughput, first-pass yield, scrap and cycle time by product, line and shift.
Nonconformance
Hold out-of-spec units and route them through NCR, MRB disposition and rework, linked to CAPA.
eDHR & genealogy
Build the device history record as production happens, ready for review by exception.
21 CFR Part 11
Electronic signatures, audit trails and access control that support FDA QMSR, ISO 13485 and Part 11.
UDI & labeling
Generate and verify labels and unique device identifiers from production data.
MES maintenance and upgrade for a US medical device manufacturer
Ongoing maintenance and support of a validated Opcenter Medical Device and Diagnostics (Camstar) system, plus a platform upgrade delivered without disrupting FDA-regulated production.
Read the case study
Guides and use cases
eDHR for medical device manufacturers
What an electronic device history record is, the regulations behind it, and how to implement it.
Read the guideCamstar to Opcenter upgrade guide
A step-by-step roadmap for moving from legacy Camstar to Siemens Opcenter Execution.
Read the guideUse cases
How manufacturers use Opcenter MES, eDHR and integration, including a client project.
See use casesFrequently asked questions
Is Opcenter Medical Device and Diagnostics the same as Camstar?
Yes. Siemens acquired Camstar and the Camstar Medical Device Suite became Opcenter Execution Medical Device and Diagnostics. Many plants still run older Camstar releases, which we maintain and upgrade.
Do you support eDHR and 21 CFR Part 11 requirements?
Yes. We configure eDHR, electronic signatures and audit trails, and support risk-based validation for FDA-regulated manufacturing.
Can you support our existing system rather than a new implementation?
Yes. We provide ongoing maintenance and support for production MES systems, including incident resolution, fixes, enhancements and upgrades.
Ready to modernize your factory?
Tell us about your plant, systems and goals. A consultant will reply within one business day with a practical next step.