Overcoming the medical device manufacturing challenge
Navigating the transition to EU medical device regulation (EU MDR) and in vitro diagnostic regulation (IVDR) is more than a regulatory hurdle; it is a business-critical mission to ensure product safety and traceability.
Whether you are scaling production for cardiovascular stents or developing next-gen diagnostic devices, your facility must eliminate contamination risks without compromising throughput. Our "inside-out" approach provides the technical certainty needed to turn these regulatory complexities into operational gains.
High-precision engineering environment you can trust
Our integrated approach ensures that the mechanical and electrical environment, from precision HVAC to high-purity water and compressed air, is built for reliability and scalability. By adapting existing buildings or creating ground-up facilities tailored to specific medical processes, Equans Sci-Tech ensures manufacturers can scale from R&D to commercial production without technical bottlenecks or production downtime. As a specialist partner, Equans Sci-Tech mitigates risk by providing single-source responsibility for the entire project lifecycle.
We provide the new build, fit-out, and reconfiguration solutions required to support delicate assembly while maintaining strict contamination control.
- ISO 14644 cleanrooms (Class 5–8)Controlled environments designed for your sterile assembly, injection moulding, and electronic component fabrication.
- Sterile packaging & filling linesValidated zones for your final primary packaging of devices, ensuring integrity is maintained until the point of care.
- Precision process utilitiesExpert integration of clean dry air (CDA), specialised gases, and high-purity water systems required for your manufacturing processes.
- Assembly & testing laboratoriesFunctional spaces designed for high-precision metrology, quality control, and R&D testing.
Find the answer to your questions
We integrate global regulatory requirements into the initial Define stage of our process. This ensures all validation protocols and documentation meet audit standards from day one, preventing costly delays during the "Deliver" phase.
Yes. We specialize in the refurbishment and expansion of environments within live sites. By using phased delivery, we ensure your manufacturing continues, and your supply chain remains uninterrupted during construction.
We frequently deliver cleanrooms ranging from ISO Class 5 to Class 8. These are tailored specifically to your process, whether you require sterile assembly or secondary packaging.
We provide single-source responsibility for all utilities. This ensures that high-purity water, gases, and HVAC systems are seamlessly integrated into your environment's control system for maximum uptime. Explore more about our process engineering
This approach means the project begins by identifying the client's specific needs, challenges, and workflows first. Discover our approach
Discover more
We bridge the gap between technical engineering and clinical requirements through a seamless, total-project model. Explore how our in-house specialists guide you through the Define, Design, and Deliver stages to provide a fully validated, turnkey environment for your medical device manufacturing
