Ciencias de la Vida y Salud
The IVDR tightened manufacturing controls. The compliance gap is a facilities gap.
The market in detail
The transition to IVDR 2017/746 has raised the bar for manufacturing controls among diagnostic kit producers. Classified production environments are now a baseline requirement, not a differentiator. We deliver ISO cleanrooms for reagent production, assembly and packaging — with environmental monitoring programmes, IQ/OQ documentation and technical documentation structures aligned with the IVDR and FDA 21 CFR Part 809 for dual-jurisdiction programmes.
Moisture-sensitive production processes addressed through our Controlled Atmosphere Rooms capability. Quality control laboratories for analytical validation under ISO/IEC 17025 integrated into the project scope from the design phase.
We design and build ISO 14644-1 cleanrooms (Class 1 to Class 9) as turnkey solutions.
See more →Entornos controlados aplicables
Dry rooms, inert atmosphere and ATEX zones where standard air is incompatible with the product.
See more →Entornos controlados aplicables
We design and build ISO 14644-1 cleanrooms (Class 1 to Class 9) as turnkey solutions.
See more →Entornos controlados aplicables
Dry rooms, inert atmosphere and ATEX zones where standard air is incompatible with the product.
See more →Entornos controlados aplicables
We design and build ISO 14644-1 cleanrooms (Class 1 to Class 9) as turnkey solutions.
See more →Entornos controlados aplicables
Dry rooms, inert atmosphere and ATEX zones where standard air is incompatible with the product.
See more →Entornos controlados aplicables
