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Key Benefits:
- Device design and development
- Global manufacturing footprint (Europe, US, Asia)
- ISO Class 7 & 8 cleanrooms
- Regulatory expertise (FDA, CE, MDR)
- Flexible for both clinical and commercial scale
Scalable MedTech & Pharma Innovation
Bringing a product to market takes more than technical expertise. It requires regulatory precision, manufacturing flexibility, and a partner with a deep understanding of medical and pharmaceutical device development.
Sanner’s device design, engineering, and manufacturing teams in Europe, the US, and Asia, deliver seamless CDMO services from early development through molding, automation, and packaging.
Our teams engage early and remain involved throughout the process, whether providing full-service development or focused support at a specific phase.
Our CDMO Approach: Precision Engineered. Seamlessly Delivered.
We involve experienced stakeholders from every core function at the start of each project. By embedding Design for Manufacturing and Assembly (DfMA), Human Factors Engineering (HFE), Regulatory Affairs (RA), and Quality Management Systems (QMS) early in development, we help partners avoid late-stage issues that can delay timelines or affect product feasibility. Offering full CDMO services, we build scalability into the design from the start. Our QMS, aligned with ISO 13485 and supported by cGMP-compliant processes, ensures consistency and audit readiness across the product lifecycle.
Our UK and US based design and engineering teams bring decades of experience across Human Factors Engineering, Concept Development, and Industrial Design. We specialize in early-stage concept design to explore innovative ideas and define product direction, while our industrial design expertise ensures those concepts are refined into manufacturable, user-ready solutions. By designing with patients and healthcare providers in mind, and integrating usability early through research, formative testing, and hands-on feedback, we create devices that are intuitive, clinically effective, and ready for adoption.
With deep expertise in materials science, mechanical engineering, electronics, and software, we develop devices that are both reliable and ready for scalable manufacturing. We use advanced tools – such as forensic analysis, mold flow simulations, digital twins, and rapid prototyping with 3D printing and additive-manufactured tool inserts – to identify critical issues early and deliver near-realistic samples. Every project benefits from interdisciplinary teams that accelerate design iterations and reduce time to market.
Sanner operates state-of-the-art manufacturing facilities with available capacity across three continents, delivering flexible, scalable, and fully traceable production. Our global network combines high-precision injection molding, advanced automation, cleanroom environments (Class 7&8), ESD-certified production areas and centralized material supply systems to support efficient manufacturing of pharmaceutical and medical device packaging and components. Modular facilities scale from clinical builds to full commercial production based on device requirements.
We embed environmental responsibility into how we design, develop, and manufacture. It’s not a standalone initiative but a core part of our long-term strategy, supported by ISO 50001 certification for energy management.
In 2024, Sanner received a Bronze EcoVadis rating under updated, more rigorous criteria, recognizing ongoing efforts in responsible sourcing, energy efficiency, and sustainable operations. Our design and development teams apply sustainability principles from the start, using tools like Life Cycle Assessment (LCA) to identify the most effective ways to reduce environmental impact while meeting product and performance requirements.
We offer comprehensive regulatory support, including CE marking, FDA pre-submissions, and regional regulatory filings. Our regulatory team has deep expertise in global frameworks, including FDA 21 CFR Part 820, EU MDR 2017/745, and region-specific requirements such as China’s NMPA. We support labeling, sterile barrier packaging, and compliance with medical device standards, backed by integrated PLM and MES systems for full traceability. Our ISO 13485-aligned Quality Management System, built on cGMP principles and effective risk management, ensures consistent quality, audit readiness, and scalable execution from development through production.
Why It Matters:
- Faster time to market through early collaboration and integrated development
- Fewer redesigns with built-in testing, prototyping, and cross-functional input
- Regulatory alignment integrated into each phase of development
- A clear and efficient path to global launch through structured manufacturing transfer
Device Categories
- Drug delivery systems
- Combination Products
- Medical Devices
- Digital Health
- In-Vitro Diagnostics (IVD)
Integrated Capabilities from Design to Delivery
- Human-Centered Design and Development: Design teams in the UK and the US lead early concept development, user research, and industrial design—grounded in engineering and regulatory needs.
→ Learn more about Human-Centered Design and Development
- Regulatory and Quality Expertise: Support across ISO 13485, 21 CFR Part 820, MDR 2017/745, and global submissions. We maintain design history files and guide pre-submission strategies.
→ Learn more about Regulatory and Quality Expertise
- Prototyping and Pilot Manufacturing: In-house mold-expertise, 3D printing, and additive tooling support rapid development of production-representative prototypes. Our on-site design and manufacturing transfer teams ensure the transition from prototype to production seamless and efficient.
→ Learn more about Prototyping and Pilot Manufacturing
- Precision Injection Molding and Assembly: Capabilities include single-shot and multi-shot molding, support for mechatronic device as well as semi and fully automated assembly capabilities.
→ Learn more about Injection Molding and Assembly
- Clinical and Small-Batch Manufacturing: We use ISO Class 7 and 8 cleanrooms for clinical and small-batch builds involving cold chain handling, sterile barrier packaging, regulated labeling, and integrated desiccant systems.
→ Learn more about Clinical and Small-Batch Manufacturing
- Commercial Scale-Up: DfMA-driven scale-up with IQ/OQ/PQ validation and supply chain readiness planning.
Designed for Partnership, Not Just Projects
From firmware-enabled injectors to high-volume diagnostics, we scale to meet each program’s requirements while maintaining speed and control.
- Modular cleanrooms and flexible production areas for next-generation projects
- Proven capability across full development and specialized builds
- Structured, stage-gated delivery process
- Global legal manufacturer experience
- EcoVadis Bronze rating for sustainable operations
Built on Proven Delivery and Global Trust
- Certified to ISO 13485, ISO 9001, ISO 15378, FDA, and MDR
- Over 130 years of manufacturing experience
- Achieves a 99% on-time, in-full delivery rate across global sites
- DfMA from the beginning, enabled by seamless service offerings
- Integrated desiccant technology for moisture-sensitive products
Ready to Launch Smarter?
Whether you need full CDMO support or targeted help with development or production, our global teams are ready to deliver.
