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Opcenter Execution Medical Device and Diagnostics

Opcenter Execution Medical Device and Diagnostics provides MES functionality, including electronic device history records (eDHR), for medical manufacturing.

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ensuring that a medical prosthetic device is error-free

Accelerate product delivery with the highest quality

Opcenter Execution Medical Device and Diagnostics (MD&D) helps medical device manufacturers by contributing to productivity, product quality and speed to market.

Error-proof manufacturing processes
Leverage Opcenter Execution MD&D system's intelligent data analytics to gain manufacturing insights that lead to quality and cost improvements. Our medtech MES solution standardizes data from the shop floor and digitally captures manufacturing know-how, enabling your company to shift from managing documents (often still paper-based) to managing enterprise-wide metrics.

Implement paperless manufacturing
Increase quality, efficiency and time to delivery with Opcenter Execution MD&D system's great flexibility and streamlined integration of product design, engineering and manufacturing. Our medtech manufacturing execution system (MES) decreases the likelihood of product delays, unforeseen errors and field failures – especially for new product introductions (NPIs).

Use self-auditing eDHRs and eBRs
Deliver regulatory compliance automatically and with reliable accuracy. Opcenter Execution MD&D automatically generates electronic device history records (eDHR) and electronic batch records (eBR), enforcing production processes and capturing all information associated with as-built production records. Self-auditing eDHRs and eBRs perform error-proofing and provide real-time visibility to produce consistent product quality.

Manage good manufacturing practices and regulatory compliance
Meet the challenges of ever-changing regulations and standards with a medtech MES that keeps up. The European Union's regulations for medical devices (EU MDR) and the United States' Food and Drug Administration (FDA) Case for Quality program are spearheading a worldwide transformation of MD&D regulations and good manufacturing practices. The paperless manufacturing and documentation in our solution makes your compliance easier.

Accelerate configuration and change management
Quickly adapt to changes unique to the MD&D industry, including the internet of medical things (IoMT), personalized medicine, value-based care and real-world evidence models. Innovate confidently for timely NPI such as connected devices, wearable technologies and devices-as-a-service. Opcenter Execution MD&D supports rapid production changeovers for complex products and smaller batch or lot sizes.

Medtech manufacturing execution system working in an MRI machine.
Case Study

Terumo

Pursuing digital transformation for growth
Case Study

以数字化转型带动发展

公司:Terumo America

行业:医疗器械和制药行业

位置:Somerset, New Jersey, United States

Siemens 软件:Active Integration, Opcenter APS

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