Institut Dr. Sorger GmbH

The Dr. Sorger Institute is a consulting firm specializing in the areas of medical devices and pharmaceuticals. The company's core activities include: Regulatory Affairs: Development of approval strategies for medical devices on a global scale, particularly for the European market (CE marking) and the US-American market. Medical Writing: Creation of technical documentation and clinical evaluations for medical devices. Quality Management Systems: Implementation and consulting on quality management systems according to EN ISO 13485:2016. Consulting: Advisory services for companies in the development and approval of medical devices, including gap analyses and risk analyses. The company supports customers in meeting regulatory requirements and helps them successfully bring their medical devices to market.