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We provide end-to-end solutions, guiding you from initial concept to full-scale production. Our ability to adapt to your unique requirements, coupled with our commitment to quality, sets us apart. By controlling the entire value chain, from CAD design to manufacturing in our ISO 8 cleanroom, we deliver tailored products that exceed your expectations.
Certifications
ISO 13485:2016
Ready to ship modular components to get immediate insight into early stage prototyping.
Protomed U-handle is ideal for catheter-based systems in endoscopy, urology, pulmonary and cardiovascular fields, for delivery, retrieval, injection, biopsy and resection applications.
Project Management
We manage medical device R&D projects with a structured, compliant approach, ensuring technical alignment, regulatory readiness, and efficient execution from start to finish.
Proof of Concept
We develop functional prototypes to validate technical feasibility, refine requirements, and reduce risk early in the development process.
Design & Development
Our in-house design and development services transform validated concepts into robust, well-documented designs ready for downstream manufacturing.
Verification & Validation (V&V) Testing
We conduct tailored V&V testing to confirm that products meet defined requirements, performance expectations, and regulatory standards.
Preclinical Testing
We support preclinical evaluation through compliant testing programs that assess safety, biocompatibility, and performance prior to clinical studies.
Manufacturing Support
We support the transition from R&D to production, from small-scale builds to scalable manufacturing in controlled ISO 8 cleanroom environments.
We provide end-to-end solutions, guiding you from initial concept to full-scale production. Our ability to adapt to your unique requirements, coupled with our commitment to quality, sets us apart. By controlling the entire value chain, from CAD design to manufacturing in our ISO 8 cleanroom, we deliver tailored products that exceed your expectations.
From idea to market: a complete guide for launching your medical device startup including design, regulation, prototyping, funding, and post-approval steps.

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