Clean room services
Clean room services
Service 2: Design Verification, Testing and Engineering Support
CYTO365 provides design verification, testing and engineering support to help EIC beneficiaries prepare medical devices and diagnostics for clinical validation, regulatory approval and commercial manufacture.
The service supports projects from TRL 3 to TRL 8 through structured engineering activities, including design input, requirements specification, design reviews, risk management in accordance with ISO 14971, verification planning and technical documentation.
Our in-house laboratory supports verification activities through ASTM F1980 accelerated ageing using a climate chamber, together with testing related to ISO 8536-4, ISO 8536-8 and ISO 8536-10. Project-specific verification methods and test protocols can also be developed where required.
Engineering services include prototype evaluation, Design for Manufacture (DfM), manufacturing process optimisation and support with design changes identified during verification or pilot production.
The objective is to reduce technical and regulatory risk before clinical studies and market launch by providing practical engineering expertise alongside laboratory verification and quality management under an ISO 13485-certified Quality Management System.
By combining engineering, testing and quality expertise under one roof, CYTO365 enables innovators to shorten development cycles, strengthen technical documentation and improve readiness for clinical validation, regulatory submissions and commercial manufacture.
Service 3: Product Development, Quality and Manufacturing Readiness
CYTO365 supports EIC beneficiaries in transforming innovative concepts into manufacturable, regulatory-ready medical technologies. The service combines product development, quality management and manufacturing expertise to reduce development risk and accelerate the transition from prototype to market.
Support includes design input, product requirements specification, Design for Manufacture (DfM), engineering reviews, manufacturing process development, risk management in accordance with ISO 14971, technical documentation and implementation within an ISO 13485-certified Quality Management System.
Projects can benefit from guidance throughout design transfer, pilot manufacturing and early production, ensuring that products are developed with future manufacturing scalability, quality and regulatory compliance in mind. Our multidisciplinary team assists with design optimisation, manufacturing documentation, supplier selection, process improvements and production readiness.
The service is particularly suited to EIC beneficiaries progressing from TRL 4 to TRL 9, helping bridge the gap between research, clinical validation and commercial manufacture through practical engineering and manufacturing expertise rather than consultancy alone.
By integrating product development, quality management and manufacturing under one roof, CYTO365 enables innovators to build robust, scalable and production-ready medical technologies while reducing technical, regulatory and commercialisation risks.
Patricia Teixeira Mendes
Quality Manager
Micael Törnblom
Mechnical Engineer, CAD
Åsa Ferm
Assembly & Quality Controller
Co-funded by EIC Accelerator Project no. 190103560 Your own Office space
Your own office in a collaborative innovation environment
Enjoy a dedicated, lockable office with 24/7 access in a professional setting designed for growing businesses. Monthly tenants benefit from complimentary use of two fully equipped meeting rooms, shared kitchen and dining facilities, high-speed internet, and office printer/scanner access. Connect with like-minded innovators while maintaining the privacy of your own workspace.
Open Co-working / Hot desk
Flexible workspace when you need it
Choose a daily hot desk or monthly co-working membership in a modern, collaborative environment. Enjoy access to shared kitchen and dining facilities, high-speed internet, office printer/scanner, and comfortable workspaces. Daily users can book meeting rooms by the hour, while monthly members enjoy complimentary access to two conference rooms—ideal for client meetings, presentations and team collaboration.
Well situated in Helsingborg Sweden in the middle of Öresund region, your warehouse needs are covered with flexible rental plan spanning from a single EU pallet to a full rack at your disposal as your needs grow. With educated personell we can pick your produced goods and ship them as per your instructions.
Contact us now regarding Clean room rental availability – starting Aug 2026
The company
CYTO365 is a Swedish Medtech company founded in 2013 and has since filed over 100 patents.
We have designed and developed the RondelO™ selector valve from idea to marker launch. It included every step from Design input, Requirement specification, Risk Analysis, and to set up ISO13485 for medical component manufacturing and Distribution of Infusion sets. Today RondelO™ is being used in multiple countries for oncology treatments where it is critical to avoid drug mixing.
We have invested heavily in industrialisation and automation for assembly in our own cleanroom in Helsingborg with capacity of 20 million RondelO™ per year. The cleanroom is ISO class 7 and GMP-C and is suitable for production towards medical and BioProcess applications.
We are co-funded by the European Union.
CYTO365 AB, Certified ISO 13485 Quality management system.
Clean room rent Sweden -
(Hyra renrum Sverige)
Rent clean room for inital production with us in Helsingborg Sweden, Clean room for clinical validation, single use assemblies for BioProcess, ISO class 7 and GMP-C standard.