It is the process through which we transfer ready dossiers and know-how to enable you to become a legal manufacturer.
Phases: assessment & gap, dossier tailoring (labels/UDI/suppliers), handover + training, support for submission/inspections.
Ownership: the operational ownership of the dossier is transferred to the client according to the contract.

It depends on class, required tests, and country. Typical indications:

• Gap Analysis: 4–6 weeks

• V&V/validations: 8–16 weeks (variable)

• Registrations: authority/Notified Body times vary for EU/UK, USA (510k/De Novo), GCC, China. We provide a roadmap and realistic milestones in the assessment.

No. We are a partner in regulatory, development, and quality. We support you in the selection and management of Notified Bodies, Authorised Representatives (EU/UK), and equivalent figures (e.g., US Agent, China rep) through a qualified network.

Depending on the project, we provide audit-ready packages such as:

• Tech File (MDR/IVDR), CEP/CER, PMS/PMCF, PSUR

• Risk File (ISO 14971), Usability (IEC 62366)

• IFU/labeling, UDI matrix, ISO 13485 documents (SOP, forms, evidence)

• Submission package for the country with follow-up Q&A to the authorities.