Ciencias de la Vida y Salud
The IVDR raised the bar on manufacturing controls. The compliance gap is a facility gap.
El mercado en detalle
The transition to IVDR 2017/746 has raised the threshold for manufacturing controls for 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 file 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
Salas secas, atmósfera inerte y zonas ATEX donde el aire estándar es incompatible con el producto.
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
Salas secas, atmósfera inerte y zonas ATEX donde el aire estándar es incompatible con el producto.
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
Salas secas, atmósfera inerte y zonas ATEX donde el aire estándar es incompatible con el producto.
See more →Entornos controlados aplicables
