CENIT reviews the product type, target market, timing, and decision you are trying to make.
Contact
Contact CENIT Consulting
For medical-device, IVD, SaMD, QMS, PRRC, and U.S. FDA matters. Send a scoped regulatory enquiry or book a 30-minute consult.
Message
Send a regulatory enquiry.
Include the product type, target market, timing, and the regulatory decision or obligation that needs to be resolved.
Send the relevant context.
CENIT will review the enquiry and respond with the appropriate service fit, scope question, or document request.
Next step
What happens after you send your message.
CENIT reviews your context and replies with the practical next step: a direct answer, a request for detail, or a focused scoping call.
That may be a short answer, a request for more context, or a suggestion to book a focused call.
If there is a fit, responsibilities, deliverables, confidentiality, and timing are clarified before engagement.
Service pages
Start with the relevant service page.
If the work area is already clear, the service page gives the scope, boundaries, and next step. Send a message when the right service fit is not yet clear.
Regulatory Affairs EU MDR, IVDR, FDA strategy, market-entry questions. QMS and inspection readiness ISO 13485, QMSR, procedures, audit preparation. PRRC Defined role support under MDR and IVDR. Information Security SaMD, connected-device, ISO 27001, and cybersecurity evidence. U.S. FDA Agent Foreign medical-device and IVD establishments.
Ready
Send the context. Define the next step.
Share the product type, target market, timing, and decision point. CENIT will confirm whether the matter needs a written scope, a focused call, or a specific service page.