Regulatory Strategy development for EU and US for FDA 510(k) and Regulatory Documentation development

Purpose and goal

Confirm and de-risk the EU/US regulatory pathway for the AkiMed™ bioresorbable platform and breast implant, including FDA 510(k) feasibility, and convert the strategy into a regulator-ready documentation foundation. The goal is a validated pathway and core technical documentation that enable non-clinical studies, FDA/Notified Body interactions, and next-stage clinical development.

Expected effects and result

A validated EU/US regulatory strategy with clear classification and a 510(k) predicate assessment, plus strengthened core documentation (biological evaluation plan, risk management, GSPR/technical documentation). Effects: reduced regulatory risk, faster and better-informed FDA/Notified Body interactions, strengthened internal regulatory capability, and a de-risked path to clinical development and market.

Planned approach and implementation

Skrivbordsbaserat arbete med extern regulatorisk expert QbD Group i två faser. Fas 1 (WP1–5): dokumentationsgranskning, krav för materialleverantör kontra legal tillverkare, FDA 510(k)-strategi och predicate-sökning, klinisk strategi EU/USA samt stöd för FDA Pre-Submission. Fas 2 (WP6–8): biologisk utvärderingsplan, riskhantering och teknisk dokumentation enligt EU MDR. Kunskapsöverföring sker via återkommande gemensamma arbetsmöten, med COO som intern ägare.