Sotas Limited

Sotas is a regulatory and quality consultancy working with MedTech and HealthTech innovators of all sizes, from early-stage ventures to established companies. We simplify complexity, reduce uncertainty, and accelerate safe market access by combining deep technical expertise with practical delivery. Our consultants are experienced Principal Consultants who have held senior roles in the sector, bringing hands-on knowledge across development, market access, regulatory compliance, and quality management. Clients trust us to provide clear, dependable guidance that balances innovation with compliance.

Our services include:

· Regulatory strategy and planning

· Technical documentation and design dossier development

· Global submissions and registrations (CE, UKCA, FDA)

· UKRP, EU REP, EU Importer, US Agent and US Initial Importer Services

· Post-market surveillance, PMCF and PMPF

· Management systems (ISO 13485, ISO 27001, QMSR)

· Auditing, training, and remediation

· Coaching/mentoring leaders and their teams