Anna-Karin Areskog Senior Quality and Regulatory Consultant
Anna-Karin has a medical background and has worked many years as QA manager within medical device and the pharmaceutical industry. She is a calm and experienced QA/QC professional, highly appreciated by clients for her positive approach in all kind of stressful situations. Specifically, Anna-Karin is supportive within ISO 13485, GMP, QSR, trainings, production processes, specs, purchasing, process/equipment validations, cleanroom validation. She has co-developed our IVDR training course. Anna-Karin holds a Masters degree in quality for life science, chemical engineering and has a nursing background.
“Having spent considerable time with remediation work and helping companies out of compliances issues with FDA. – How do you recommend MedTech companies to avoid such situations?” ”Serious compliance issues cost companies tremendous amount of time, money and goodwill. Medtech companies simply must realize and respect to do things in a correct and compliant way from design start and throughout the product lifecycle.”