Hamburg, Hamburg, Germany
As the Managing Director of LITERO GmbH since November 2022, I bring over three years of expertise in clinical affairs, regulatory compliance, and quality management for the medical device industry. I hold a Certified Quality Auditor (CQA) credential and offer specialized consulting services to support companies in navigating compliance pathways and ensuring market success for their medical devices. My work emphasizes clinical evaluation, post-market surveillance, and regulatory assessments, with a focus on aligning medical device processes with ISO 13485, MDR, and other relevant standards. As a certified ISO 13485 Lead Auditor and TÜV SÜD Partner, I am committed to helping clients achieve quality and regulatory excellence, whether for traditional medical devices or innovative, AI-enabled technologies.
LITERO provides a wide range of consulting services in the areas of clinical affairs, regulatory affairs, and quality management for the medical device industry. With LITERO, you gain expert guidance, regulatory and quality confidence, and market success for your medical devices. Let’s navigate the path to compliance and quality together.
Clinical strategies for medical devices for ventilation therapy and anesthesia, Clinical Evaluation Report, PMCF, Literature Assessment acc. to EBM, Post-Market Surveillance, Clinical Study, Risk Management, Clinical Claims, global Process Owner for Clinical Evaluation Report and PMCF according to MDR and MEDDEV Guidelines
QPPV, Stufenplanbeauftragte according to AMG §63a for wound and hands disinfectants Setup of the pharmacovigilance system, PSMV, Signal management (GVP Module IX) PSURs (EU-Directive 2001/83/EC and GVP Module VII), Risk Management Plans (GVP Module V) Inspections (incl. FDA) and Audits Sicherheitsbeauftragte für Medizinprodukte, Post-market surveillance for medical devices, Clinical Evaluation Report according to MEDDEV 2.7/1, Risk Management acc. to ISO14975 Literature search and assessment
Pharmakovigilance for different drugs incl. analgesics and oncological therapeutics, PSURs, DSURs, Adverse reactions reporting, Clinical Expert Statements, Literature Search