In the MD&D manufacturing industry Siemens and its Opcenter Execution Medical Device and Diagnostics (Opcenter EX MDD) can be considered as the best-in-class manufacturing execution system (MES) needed by all medical device manufacturers to meet their challenges in the industry, with particular regard to the small- to medium-sized businesses (SMB).
SMB are the emerging leaders in the MD&D market, and they need to face several additional factors to succeed in the market compared to their large competitors such as:
- Constrained resources. SMB manufacturers need to get their products manufactured “right-at-first-time”, complete the regulatory process and place their product on market faster than their competitors.
- Less experienced users and fewer support staff. SMB operators need to quickly implement new technology with minimal training.
- Speed in the compliance process. Validation process for high-risk medical devices is both time-consuming and resource-intensive.
- Acceleration of growth. SMB manufacturers must have their product to market quickly to establish a market position and but to bring potentially life-saving products to patients.
That demands an urgency around creating a digital infrastructure that supports them increasing their product quality and ensure “right-first-time” product along with rigorous detailed manufacturing traceability to reach regulatory approval.
Opcenter Execution Medical Device and Diagnostics (Opcenter EX MDD) is the leading solution that helps MD&D companies accelerate innovation for small- to medium-sized businesses, reduce cost and achieve the highest quality. Opcenter provides self-auditing eDHR and eBR, enforces good manufacturing practices (GMP) and regulatory compliance to a “right-first-time” product. It also eliminates paper from the shop floor and reduces non-value-added activities by automating the control of the 5Ms (Material, Man, Machine, Measure, Method).
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