Cosm

Cosm is a regulatory consulting firm specializing in FDA clearance and approval pathways for medical device companies, with particular expertise in Software as a Medical Device (SaMD) and AI/ML products. Founded in 2020, the company operates from San Francisco with additional presence in Mexico City and Amsterdam, serving both U.S. and international clients.

The firm's core services span the entire medical device lifecycle: regulatory strategy and FDA submissions, integrated product development guidance, Quality Management System implementation (FDA QSR and ISO 13485), clinical study design and execution, and regulatory-compliant marketing support. Their approach emphasizes integrating regulatory considerations with product roadmap decisions from the earliest stages to avoid costly pivots later in development.

Cosm has supported multiple clients through successful 510(k) clearances, with testimonials highlighting expertise in navigating complex regulatory pathways for emerging technologies. The client roster includes notable companies like Arterys, Pear Therapeutics, and iRhythm, spanning early-stage startups to established medtech firms.

Choose Cosm when developing a regulated medical device or SaMD product and need regulatory expertise that integrates with product development decisions rather than operating as a separate compliance exercise. The firm's approach works particularly well for teams building innovative technologies like AI/ML products where regulatory precedents are still evolving.

Expect a consultative engagement focused on education and strategic guidance alongside execution. Clients report gaining clarity on regulatory pathways, actionable recommendations, and sustainable quality systems that don't impede product velocity. The firm's experience with machine learning and software-based medical devices provides value for companies in emerging technology categories.

Cosm operates exclusively in the medical device sector, providing FDA regulatory services specifically for healthcare products. Their expertise centers on regulated medical technologies including Software as a Medical Device (SaMD), AI/ML-enabled diagnostics and therapeutics, and traditional medical devices. The firm's knowledge of FDA Quality System Regulation (QSR) and ISO 13485 standards is healthcare-specific.

Their client portfolio includes digital health companies like Arterys (medical imaging AI), Pear Therapeutics (prescription digital therapeutics), and various diagnostic and monitoring device manufacturers, demonstrating focus on innovation-driven healthcare technology companies.

Medical device startups and digital health companies in pre-market or early commercialization stages developing software-based or AI-enabled products. Organizations that value regulatory guidance as a strategic function integrated with product decisions rather than a compliance checklist. Companies seeking their first 510(k) clearance or navigating novel regulatory pathways for emerging technologies.