SmartPath AG

SmartPath AG is a Switzerland-based consulting firm supporting medical device and medtech companies through the challenges of development, regulation, and commercialization. Its services span the product lifecycle, from investment and feasibility work through development and ongoing market activity. The company tailors its advice to each project, helping clients address regulatory compliance, technical development, commercial viability, and organizational needs.

SmartPath’s expertise includes regulatory and R&D support, FDA strategy and compliance, Medical Device Regulation (MDR) portfolio updates, biological evaluation reports, and quality-system implementation. It also advises during due diligence for open innovation, joint ventures, and mergers and acquisitions, and provides project management to coordinate initiatives efficiently in terms of time and cost. The team has experience working with startups as well as medium and large enterprises, and has guided devices from early feasibility toward mass production.

SmartPath also supports investor-facing work and partnerships, helping clients present projects and navigate discussions with investors, manufacturers, and distributors. Its goal is to provide practical, flexible expertise that helps medtech teams move ideas toward successful products.