Medtech Consulting

Providing expertise in design, development, and contractor services, along with process optimization and quality framework establishment for medical device entities. Specialized boutique headhunting and commercial services for MedTech. Advised on high-profile M&A transactions, assisting major European MedTech groups with technology due diligence, risk assessment, and integration strategy, influencing acquisitions exceeding 500M+ PLN. Led regulatory consulting, securing ISO 13485, MDR CE, and FDA approvals for multiple clients. Established 50+ governance frameworks, including Stage-Gate NPD, Portfolio Management, and Risk-Based Design Control, streamlining commercialization. Provided strategic guidance on four major NPDs, each comprising 800+ BOM components, and conducted extensive design reviews. Developed market feasibility studies, enabling multiple startups to secure VC funding and successfully enter the European market. Spearheaded QMS implementation for five+ companies, enhancing CAPA compliance and operational efficiency.