CREATE Regulatory Affairs consultancy B.V.

Over CREATE Regulatory Affairs consultancy B.V.

CREATE is a regulatory consultancy specializing in medical device regulations, including EU MDR, IVDR, FDA, and Health Canada requirements. We support both startups and established manufacturers in achieving regulatory compliance and market access. In addition to traditional consulting, we collaborate closely with our sister company, Regulatory Augmented Intelligence (RAI), to offer AI solutions for regulatory professionals. Together, we combine regulatory expertise with smart automation, providing proprietary tools such as ChatMDR, ChatFDA, ChatIVDR and ChatAIACT .

Team per functiegebied

Gebaseerd op 5 openbare functieprofielen, stand van 4 augustus 2026.

• Research / R&D2
• Executive / C-Suite1
• Founder / Owner1
• Marketing1