Solnovis GmbH

We advise and support our clients in defining and implementing development and regulatory approval strategies for complex medical devices, in developing system risk management at the corporate and product levels, and in analyzing and implementing requirements in the areas of regulatory affairs and systems engineering. In addition, we organize workshops and seminars to share knowledge and practical experience on current topics in medical technology.

• "Quality Management Consulting (EN ISO 13485, EN ISO 9001, 21CFR820)
• EU MDR Conformity Assessment Procedures (Regulation (EU) 2017/745)
• Process Definition and Optimization
• Preparation for External Audits (FDA, Notified Bodies, Regulatory Authorities)
• Preparation and Conduct of Internal Audits
• Product Design Documentation and Requirements Engineering
• Medical Device Approval (CE, U.S., and International)
• Risk management according to ISO 14971
• Software documentation in accordance with IEC 62304
• Usability in accordance with IEC 62366
• Safety of medical devices in accordance with IEC 60601-1, specifically in the areas of
• electrical safety and EMC
• Biocompatibility in accordance with ISO 10993
• Standards and regulations in the field of optics, lasers, and LED technology"