Find Your MES
Question 1 of 27 · Regulatory intensity
Non-regulated — general industrial / consumer
No specific manufacturing regulator beyond ordinary safety + quality.
ISO 9001 / IATF 16949 / general industrial QMS
Documented quality processes, internal + customer audits, no pharma-specific regulator.
ISO 13485 / medical devices / IVDR
Regulated medical-device manufacturing — formal but not pharma-cGMP.
GxP-adjacent — clinical-supply / preclinical / CDMO development
Some 21 CFR Part 11 audit-trail and electronic-signature scrutiny; full cGMP may apply to specific products.
Full pharma cGMP / 21 CFR Part 11 / EU Annex 11
Commercial pharma manufacturing — batch release, regulator-inspectable, audit-ready.