Critical Catalyst provides a wide range of regulatory and technical consulting services, guaranteeing full compliance of medical software/appmedical devices, biocidal, medical grade protective equipment, cosmetic products and food supplements with all applicable legal requirements across international markets. Our portfolio includes manufacturers and distributors from several industries worldwide.

regulatory AffaiRS

CE Marking
Technical File
EN ISO 13485
EU Authorised Representative

Safety Assessment Report
Product Information File
Product Claims & Allegations
CPNP Notification

Conformity Assessment
Nutrition & Health Claims
Health Authorities Registration
Scientific Data Review