GBA Key2Compliance

medical devices

About

GBA Key2Compliance is a consulting and training company focused on the medical device, in vitro diagnostics (IVD), and pharmaceutical industries. Established in 1994 in Stockholm, Sweden, it has become a leading provider in the Nordic region, employing over 70 experts across multiple offices in Stockholm, Lund, Gothenburg, and Copenhagen. The company specializes in regulatory compliance solutions, offering services in quality assurance, regulatory affairs, clinical development, biological safety assessments, and customized training. GBA Key2Compliance supports medical device manufacturers, IVD companies, and pharmaceutical firms by facilitating the implementation of regulatory requirements and quality standards throughout the product development lifecycle. In 2020, it was formed from the merger of Symbioteq Kvalitet AB and Key2Compliance, and in January 2024, it joined the GBA Group, enhancing its service offerings and international reach.

Technologies

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Keywords

quality assurance regulatory affairs clinical development biological evaluations toxicology training education pharmaceuticals life science medical device clinical evaluation gxp qms gmp gdp biopharmaceuticals compliance compliance seminars consultancy mdr ivdr iso13485 gcp glp medical equipment manufacturing in vitro diagnostic software post-market surveillance medical devices in vivo testing medical device software

Location

44 Skeppsbron, Stockholm, Stockholm County, Sweden, 111 30

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