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Sanner’s design transfer process provides a smooth handoff of the frozen design from engineering development to scalable production through carefully planned phases that prevent costly rework and support uninterrupted global manufacturing.
Designed for Scale from the Start
Designs progress more efficiently when production planning starts early. At Sanner, cross-functional teams, including engineering, quality, regulatory, design transfer and manufacturing, assess manufacturability, material performance, assembly methods, and tooling requirements in collaboration with leading mold, manufacturing machinery, and automation suppliers worldwide.
Prototyping and early testing help identify and resolve issues before full-scale production. During this phase, Sanner’s engineering, quality, regulatory, and manufacturing teams apply Design for Manufacturing and Assembly (DfMA) principles to reduce the risk of costly redesign activities and help avoid delays.
Virtual simulations support layout planning, workflow optimization, and equipment selection well in advance of launch. Our engineering, quality, regulatory, and manufacturing teams stay aligned throughout the process, delivering formal knowledge transfer and training to ensure production teams are fully prepared for a smooth ramp-up.
Pilot Builds and Smooth Ramp-Up
Sanner ensures a smooth transition from early-stage builds to serial production through close coordination between our in-house engineering and automation teams. Using advanced techniques such as, additive manufactured tool inserts, we create parts in production-intent materials early in the process, accelerating iteration cycles and resolving design challenges before launch.
Our team guides each project through structured design transfer checklists and review meetings to ensure risk management, validation, and regulatory compliance are addressed before handoff. Our validation process follows a robust IQ, OQ, and PQ framework aligned with regulatory requirements to minimize delays and streamline approvals.
Aligned for Compliance and Continuity
We deliver complete, well-structured design transfer packages that support continuity across sites. Each package includes comprehensive documentation, such as the Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR), to support regulatory submissions and audits. Whether manufacturing stays within the Sanner network or transitions to a partner, the handoff remains clear and production-ready.
Built for Industrialization
Infrastructure, systems, and global execution capacity support Sanner’s ability to deliver a seamless transfer from design to production.
Certified Facilities
- ISO 13485 & cGMP standards
- Global compliance & consistent product quality
- Implementation of pilot builds
Global Capacity
With 28,500 square meters of production space and 11,000 square meters of cleanroom space (Class 7 & 8) across Europe, the US, and Asia, Sanner has the scale to support complex device programs from pilot runs to full-scale manufacturing.
Process Simulation and Prototyping
Using mold flow simulations and advanced prototyping, including additive-manufactured mold inserts, Sanner identifies and resolves manufacturing challenges early, minimizing costly late-stage changes, optimize tooling and ensuring a smoother transition to full-scale production.
Structured Validation
Sanner’s validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), are aligned with global regulatory requirements and integrated into a structured framework that minimizes rework and keeps timelines on track for commercial launch.
Quality at each stage
This framework is developed closely with our quality and production teams, combining the V-model methodology with rigorous risk assessments. With support from the in-house quality lab, this approach reduces delays, accelerates approvals, and ensures full compliance, supporting a faster, more confident path to market.
Full Traceability
Sanner integrates PLM (Product Lifecycle Management) and MES (Manufacturing Execution Systems) platforms to ensure real-time data tracking, manage production documentation, and maintain complete traceability throughout the transfer process. These digital tools enhance efficiency, minimize errors, and improve overall process visibility, supporting timely and accurate production transitions.
Ready to move from design freeze to production?
Connect with Sanner to discuss your transfer and industrialization needs. Our global teams are ready to support you at any stage.