Regulatory and quality management consulting services for medical device and IVD manufacturers. Provides expertise in UK, EU, and US regulatory compliance, device registration, management systems, post-market surveillance, and in-country representation throughout the product lifecycle.
Manufactured by
Sotas Limited
Pembrokeshire, United Kingdom
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: · Coaching/mentoring leaders and their teams · Regulatory strategy and planning · Technical documentation and design dossier development · Global submissions and registrations (CE, UKCA, FDA) · UKRP, EU-REP, EU-Importer and US Agent services · Post-market surveillance and PMCF · Management systems (ISO 13485, ISO 27001 implementation and ongoing compliance support).
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