Ciencias de la Vida y Salud
MDR 2017/745, FDA QMSR, ISO 13485 — classified environments built to pass both the Notified Body and the FDA with the same documentation package.
The market in detail
Medical device manufacturers face a dual compliance challenge: ISO 14644 classification for the production environment and the complete technical documentation demanded by Notified Body scrutiny under Regulation (EU) 2017/745. Both within a single project scope — with IQ/OQ protocols, ISO 13485 quality management system integration and ISO 14971:2019 risk management documentation structured for technical documentation submission.
For programmes destined for the US market, facility documentation aligns with FDA 21 CFR Part 820 QMSR (in force 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
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
