AkiMed-c12: The Next-Gen Bioresorbable Breast Implant

Purpose and goal:

Akira Science is a deeptech start-up, specializing in innovative medical device solutions. Their product, AkiMed-c12 revolutionizes soft tissue regeneration with its non toxic, degradable, biocompatible, and 3D printing compatible properties. Akira Science aims are to make their innovative solution widely accessible, establish a strong market presence, and contribute to advancements in breast tissue reconstruction and medical technology.

The goal of this project is to design the regulatory activities that will be required to obtain CE-mark. Expected results and effects: - Regulatory plan for bringing AkiMed-c12 to clinical trials. - Design of preclinical model for next study. - Technical documentation to prepare for clinical evaluation.

Approach and implementation: 1. Project preparation including reading and revision of existing documentation and literature. 2. Brainstorming sesion between QAdvis and Akira Science to define general status and intended use of the product. 3. Review and process quality management system of the potential medical device.

4. Regulatory plan for bringing AkiMed-c12 to clinical trials (transfer of knowledge).