Opcenter Execution Medical Device and Diagnostics (MDD) is an industry leading manufacturing execution system, serving the life sciences and medical device industries. It empowers medical device manufacturers by contributing to productivity, product quality and speed to market. Opcenter Execution MDD supports error-proofing manufacturing processes, paperless manufacturing, as well as delivering proactice and self auditing electronic device history and batch records. Confidently manage regulatory compliance and good manufacturing practices via the feature-rich set of capabilities. It also enables configuration and change management acceleration through a robust set of configuration and master data management tools.
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 MDD& 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) 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.
Highlights
Opcenter Execution Medical Device and Diagnostics (MD&D) helps medical device manufacturers by contributing to productivity, product quality and speed to market
Implement paperless manufacturing and iIncrease 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 which 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
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Pricing is based on the duration and terms of your contract with the vendor. This entitles you to a specified quantity of use for the contract duration. If you choose not to renew or replace your contract before it ends, access to these entitlements will expire.
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This listing uses a contract pricing model with a single dimension: a custom quote for one year of service. Pricing is not fixed on the Marketplace. Instead, you request a quote from the vendor, who sets the price based on your needs. The one-year term covers the manufacturing execution system for medical device and diagnostics production, including electronic device history records. Because there is one quote-based dimension, pricing scales according to the scope agreed with the vendor rather than through preset tiers or instance sizes.
Top-of-mind questions for buyers
What determines the price of the one-year custom quote?
The vendor sets your price based on your specific needs and deployment scope. There are no preset tiers or instance sizes on the Marketplace. You request a quote, and pricing reflects the scope you agree with the vendor for one year of service.
What does the one-year term include for medical device manufacturing?
The term covers manufacturing execution system (MES) functionality for medical device and diagnostics production. This includes electronic device history records (eDHR) and electronic batch records (eBR). It also supports paperless manufacturing, configuration and change management, and regulatory compliance documentation.
Is this a one-time purchase or does it renew?
Pricing is quoted for a one-year term. The custom quote covers 12 months of service. For details on renewal or extending beyond the year, contact the vendor, since renewal terms are set as part of your quote agreement.
Request a private offer to receive a custom quote.
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This data package contains the Clinical Laboratory Improvement Amendments (CLIA), mammography facilities certified by the Food and Drug Administration (FDA), radiation-emitting electronic products data, Computed Tomography of head and Magnetic Resonance Imaging of head data.
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