Services

Regulatory strategy and approvals

EU MDR/IVDR and UKCA pathways, FDA 510(k), De Novo and PMA strategy, SaMD classification, regulatory roadmapping, Notified Body and FDA engagement, and submission authoring.

Quality systems and risk

ISO 13485 implementation, gap closure and scaling; ISO 14971 risk management; design controls and DHF/DTF; internal audits, supplier qualification and audit readiness.

Technical documentation and clinical

Technical files and design dossiers, clinical evaluation plans and reports, verification & validation strategy, PMCF and PMS planning, vigilance and remediation support.