Confinis

Confinis General Information

Description

Founded in 2005, Confinis is an accounting and auditing firm headquartered in Dudingen, Switzerland. The firm, now part of Athagoras Group, is a regulatory consultancy specializing in providing advice and services to the medical device, combination product, and IVDD manufacturers. The firm core competences are in business practices quality management and regulatory affairs services, design control, clinical evaluation, software development life-cycles (e.g. IEC 62304), product risk management (ISO 14971), human factors (IEC 62366-1), electrical safety (IEC 60601-x), validation (computer system validation, process validation, GAMP 5, 21 CFR Part 11 etc.), remediation activities, auditing, training and project management, with particular expertise in new product development from idea through registration to commercialization and post-market activities.