Regulatory and Quality management expertise for MedTech Innovation

Purpose and goal

CSW Therapeutics is revolutionizing treatment of refractory angina using a non-invasive wearable therapy device for myocardial revascularization. It stimulates regenerative cell growth in cardiac tissue using shockwave therapy (CSWT). The goal of this project is to strengthen the teams’ internal regulatory and quality management capabilities to accelerate readiness towards clinical validation and future EU MDR and FDA approval pathways.

Expected effects and result

The project will strengthen in-house competence, accelerating clinical and commercial readiness of the wearable CSWT device. Specifically, it will result in: - A regulatory roadmap toward FIH studies and CE marking. - Technical documentation structures aligned with EU MDR. - Risk management and QMS procedures aligned with ISO 14971 and ISO 13485 for the current development stage. - Internal regulatory templates, workshops, and authority-interaction simulations.

Planned approach and implementation

The project is divided into three main work packages covering: 1) assessment of the current regulatory and quality management stage within the organization, 2) implementation of improved practices with support from the hired expert, and 3) establishment of sustainable internal competence in regulatory and quality management. 1. Regulatory documentation review and gap analysis (May ´26) 2. Regulatory and QMS implementation (May–Aug ´26) 3. Knowledge transfer and consolidation (Aug–Oct ´26)