Laura Klink

LS medcap GmbH

LS medcap GmbH is an entrepreneurial Family Office and Medical Device Service Provider with a focus in Life Sciences and Clinical Research. Our expertise covers the support of medical device manufacturers and medical technology companies from the pre-market to the post-market phase: Scientific Affairs – Clinical evaluation acc. to MDR and MEDDEV 2.7/1 rev.4, systematic literature search and analysis as well as consulting Quality Management & Regulatory Affairs – Strategies and certification for QM systems, validation of processes and equipment as well as risk management and regulatory affairs Clinical Affairs – Clinical investigations and PMCF studies for medical devices incorporating project planning & management, vigilance, data management, clinical monitoring and quality assurance in compliance with MDR / ISO 14155 requirements. Laboratory – Clean room monitoring, microbiological and sterility testing for water samples and medical devices LS medcap GmbH Lotzenäcker 6 72379 Hechingen, Germany +49 (0) 7471 984 80-0 www.lsmedcap.com