Ciencias de la Vida y Salud
MDR 2017/745, FDA QMSR, ISO 13485 — classified environments built to pass the Notified Body and FDA with the same documentation package.
El mercado en detalle
Medical device manufacturers face a dual compliance challenge: ISO 14644 classification for the production environment and the complete technical file required by Notified Body scrutiny under Regulation (EU) 2017/745. Both in a single project scope — with IQ/OQ protocols, ISO 13485 quality management system integration and ISO 14971:2019 risk management documentation structured for technical file submission.
For US-market programmes, facility documentation aligns with FDA 21 CFR Part 820 QMSR (effective February 2026, harmonised with ISO 13485:2016). Vibration-sensitive device assembly addressed through our Technology Spaces capability.
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
