Alex Zaretsky

Background

About Alex Zaretsky

Who I help: SaaS, AI and MedTech leaders who need to launch, scale, and comply in Europe and North America. What I do: I turn complexity into clarity at the intersection of: 1. Business strategy & fundraising 2. AI/SaaS medical device R&D 3. Quality & regulatory governance How I add value- Startups & scale-ups: from fundraising ($15M raised, 2 exits) to product launch and compliance- Established companies: aligning business, engineering and regulatory teams to speed audits and maximize ROI- Investors & boards: de-risking AI/MedTech portfolios by embedding scalable QMS, regulatory readiness, and product-market fit. Why it works: I’ve spent over a fiften years of bridging AI research (PhD in AI-enabled medical devices) with real-world impact: building teams, shaping business and product strategies, working directly with regulators (FDA, EU, Health Canada, PMDA)- Expertise: MDR, FDA, ISO 13485 / 42001 / 27001, MDSAP, SW and AI lifecycle mgmt- Strength: systems thinker who turns bottlenecks into enablers- Soft skills: leadership, critical thinking, resilience, and a bias for action. Next step: If you want to ship AI/SaaS that pass audits without destryoing your business processes, win funding, and validate your business and product ideas faster, let’s connect.