Regulatory support - US market for innovative biopsy needle

Purpose and goal

The purpose of this project supported by Vinnova 2018 is for NeoDynamics to build knowledge around the US legislation related to MedTech products. This will aid adapting our processes as needed for developing products with the appropriate supporting technical documentation In addition the project shall result in a regulatory strategy for applying to FDA in order to get market clearance for the biopsy system NeoNavia currently developed by NeoDynamics.

Expected results and effects

The complete set of project goals for 2018 was achieved aided by the grant from Vinnova. The expected outcome is thus for NeoDynamics to submit a complete 510(k) submission to the FDA towards end 2019 in order to achieve market clearance for NeoNavia in the US. In summary the following goals were achieved 2018 within the scope of this project: - Quality system updated to meet QSR, US legislation - Project documentation reviewed in light of the updated quality system - FDA Pre-sub meeting completed in order to fine tune the regulatory strategy for NeoNavia

Planned approach and implementation

The Vinnova grant has been used to secure relevant specialist competence. Local contractors focused on quality system, medical technology and related regulatory matters. In addition we also partnered with a well renowned US regulatory agent within the medical technology field who got to focus completely on the FDA submission strategy. The project was conducted using these specialist resources for reviewing and consultation while having NeoDynamics resources do major parts of the footwork in order to ensure competence build-up long term. The set-up has been highly effective!