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Sanner provides clinical manufacturing for investigational medical devices and combination products, including drug-device integrations and personalized treatments. As these products grow more complex, cleanroom infrastructure and design-for-manufacture expertise support early-phase builds across a range of formats and study types.
Clinical Trial Manufacturing
We support early-phase clinical evaluation with builds that emphasize usability, patient safety, and consistent performance. By aligning manufacturing with study protocols and actual use environments, we help verify design intent and its functional performance during clinical evaluation.
- Engineering and pilot builds for IMDs and DDCs
- Small batch builds for non-sterile and sterile assemblies, with external partners supporting sterilization as needed
- Configurable manufacturing setups based on study protocols
- Usability-informed feedback loops during product iteration cycles
- Custom modifications to support trial-specific functionality
Design and Engineering Support for Clinical-Stage Success
Sanner guides early-stage concepts into clinical-ready builds with efficiency and precision, using advanced design-for-manufacture and design-for-assembly (DFMA) strategies. Our cross-functional teams support verification, validation, and small-batch production by identifying risks early and ensuring a seamless transition to manufacturing.
- Comprehensive design evaluations for clinical feasibility
- Forensic engineering to identify and resolve performance risks
- Iterative prototyping and simulation to improve device usability and manufacturability
- Targeted design modifications for clinical optimization
- Transition planning to support future commercial builds
Global Capacity, Regulatory Confidence
Sanner operates a global network of CDMO facilities with more than 11,000 square meters of ISO 7 and ISO 8 cleanroom space. Our facilities accommodate both small-scale pilot projects and large-scale commercial production, supporting the full spectrum of medical device and healthcare packaging needs.
Our sites follow established quality management systems aligned with major international regulatory frameworks. We ensure audit readiness and regulatory alignment across every batch, supported by complete documentation, full traceability, and supplier compliance controls.
- DIN EN ISO 13485:2016
- EU MDR (2017/745)
- FDA 21 CFR Part 4.4(b)(2) for combination products
- Hybrid QMS integration with 21 CFR Parts 820 and 211
Find out more about Sanners´capabilities on Commercial Manufacturing
Worldwide Capabilities with Specialized Support for Clinical Manufacturing
By prioritizing patient-centric design and clinical applicability, we ensure device development accounts for critical factors: end-user workflows, contextual usage environments, and patient interaction patterns. This focus enables robust clinical batch manufacturing that validates product designs through real-world testing and clinical trials while maintaining scalability for commercial production.
More information about human-centered design
As strategic partners, we bridge the gap between development and clinical validation by embedding user feedback loops into manufacturing processes. Our advanced production capabilities and quality-driven workflows facilitate smooth transitions from prototype iterations to trial-ready devices, ensuring designs meet both functional requirements and patient acceptance criteria before market entry. All Sanner sites operate under unified quality and regulatory systems, with certifications including cGMP, FDA, EMA, and ISO 13485.
We have the global capacity and technical depth to deliver at every stage.
Sanner’s global teams work across design, engineering, manufacturing, and regulatory functions to keep projects moving forward. With deep technical capabilities and tightly integrated processes, we help accelerate development and deliver consistent results at every stage.
Looking to streamline your next build?
Connect with our team to discuss how Sanner supports investigational and combination devices from prototype through clinical trials. We help you navigate manufacturing, regulatory, and engineering requirements with clarity and confidence.