As part of a continued focus on delivering high-value RA/QA consulting for medical device companies, Medicologic has hired Eva Steinick in the role as Senior Quality Management & Regulatory Affairs Consultant.
Eva has more than 30 years of experience within Quality Management and Regulatory Affairs, both as manager and hands on. Eva’s experience covers both medical devices and in vitro diagnostic devices.
Eva is a trained lead auditor and she has conducted numerous internal and supplier audits in Europe and North America.
Eva has submitted several international registration files for Class III medical devices and in vitro diagnostic devices and handled complaints, non-conformities and CAPAs, risk management, adverse incident reporting and Field safety corrective actions.
She has been part of implementation of Quality Management systems, writing and updates of procedures, and GAP analyses.
Eva is an expert in Design Controls and she has also worked as Project Manager in the telecom industry.
Furthermore Eva is a dedicated person who strongly believes that every problem has (at least) one smart solution.
According to Partner Randi Hauerberg, this is yet another positive addition to our expertise across all major RA/QA areas. “Eva has worked with medical devices and in vitro diagnostics and has extensive knowledge when it comes to EU Directives, FDA regulations, EU harmonized/internationally recognized standards and MEDDEV guidances – all areas where experience plays a key role in obtaining a fast and smooth process for obtaining approvals for our clients. I am sure Eva will prove a major asset for us and help our clients succeed in this very dynamic and complex market”.