By seamlessly transferring designs from development to production within a single trusted partner, Sanner ensures faster market readiness, minimized transition risks, and scalable long-term manufacturing, supporting product commercialization while saving you time, cost, and complexity.
Sanner specializes in medical device design transfer, with a process provides a smooth handoff of the frozen design from engineering development to scalable production, through a carefully phased approach that prevents costly rework, ensuring production readiness at every stage.
Manufacturing constraints are often addressed too late into product development. Sanner’s transfer teams ensure manufacturing requirements are considered from the start, proactively managing critical considerations to ensure a seamless path to market
Responsibility for the product gradually shifts as it advances through the development stages:
Sanner’s teams integrate design transfer long before design freeze to reduce industrialization risk and accelerate market readiness. Our teams deliver value from pre-design freeze through pre-commercial builds and into full manufacturing. We continue to support product changes throughout the entire lifecycle.
Before transfer begins, our Design Transfer team evaluates the device and recommends pre-transfer changes to discover and mitigate potential risks before production begins.
Sanner transfers medical device and combination product manufacturing between our global facilities and from external partners using a proven technology transfer process that includes documentation review, equipment qualification, and Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The result is a smooth transition to production with validated manufacturing processes, consistent product quality, and minimal disruption.
Sanner’s Design Transfer Engineers serve as the bridge between product development and manufacturing. Cross-trained in project management, product engineering, and manufacturing engineering, they coordinate the transfer of products from our design and development centers. Working closely with quality, regulatory, supply chain, and operations teams, they ensure every transfer is executed efficiently, with complete documentation, validated processes, and a clear path to scalable production.
With over 28,500 m² (300,000+ sq ft) of production space and 11,000 m² (118,000 sq ft) of ISO Class 7 and 8 cleanroom space across Europe, the US, and Asia, Sanner has the scale to support complex device programs from pilot runs to full-scale manufacturing.
Sanner operates under an ISO 13485 certified quality system built on rigorous quality assurance, with FDA-registered and cGMP-compliant sites. Our hybrid QMS supports combination products under FDA 21 CFR Part 4, integrating 21 CFR Parts 820 (QMSR) and 211, alongside EU MDR (2017/745) compliance.
End-to-end development and manufacturing for a product that helps surgeons collect and use bone for grafting.
End-to-end development and manufacturing for an innovative anesthetic spray.
End-to-end development and manufacturing for an innovative IV bag.
