Litero Gmbh

Our CEO: Dr. Kristijana Milovic Holm Contact: info@litero-agency.com LITERO GmbH specializes in Quality Management, Regulatory Compliance, and Clinical Affairs for the medical device industry. With 20 years of hands-on experience, we provide strategic expertise and practical solutions to help companies meet the evolving requirements of MDR, ISO 13485, and global regulatory frameworks. We bring deep expertise across traditional medical technologies as well as Software as a Medical Device (SaMD) and AI-driven medical devices, ensuring compliance with software lifecycle standards (IEC 62304), emerging AI regulatory expectations, and MDR requirements for digital and algorithm-based technologies. With LITERO, you gain expert guidance, regulatory and quality confidence, and true partnership on your path to market success. Let’s navigate the path to compliance and quality together. Our expertise includes: Quality Management & Auditing – Development and maintenance of ISO 13485–compliant QMS, SOPs, internal and supplier audits, audit preparation, and quality processes aligned with IEC 62304 for software-based and AI-enabled medical devices. Regulatory Compliance & PRRC Services – Comprehensive MDR compliance, strategic regulatory support, and PRRC services in alignment with MDR Article 15. Clinical Strategy & Documentation – Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Summary of Safety and Clinical Performance (SSCP), Post-Market Surveillance (PMS), and Post-Market Clinical Follow-ups (PMCF). Certified Auditor & TÜV SÜD Partner – Expert auditing services for ISO 13485 and MDR, including active and software-driven medical technologies. Let’s simplify complexity in quality, regulatory, and clinical affairs—helping your medical devices reach the market successfully. Contact us to learn how we can support your regulatory, quality, and clinical success.