Regulatory services include FDA device clearance (510(k), PMA, etc.), CE marking (technical file preparation, post market activities, etc.), support in clinical trial approvals, clinical trial support and set-up and maintenance of quality management systems in our customers’ organizations. We support customers with regulatory approvals and country registrations in Europe, the United States and elsewhere. Our long-standing working relationships with notified bodies support an early, collaborative assessment of regulatory strategies. For new start customers who do not yet have an ISO certified quality management system, we offer to hold regulatory approvals (e.g., CE mark) for products on behalf of our customers.