Azadeh Haijpour
Azadeh, a senior Quality and Regulatory consultant at GBA Key2Compliance within the Medical Device industry, brings extensive experience and expertise in regulating and implementing agile frameworks, risk management, safety, information/cybersecurity standards and other applicable regulations within the life sciences industry. Azadeh has worked with both small and large companies to ensure compliance and has supported […]
Thomas Doerge
Global Head AIMD and SaMD, BSI Thomas Doerge has an in-depth knowledge of Biomedical Engineering, Neuroprosthetics, Neuromodulation and Software, which includes Design and Manufacture of Neuromodulation systems and Software Development for stand-alone applications and hardware embedded software. He leads a global team of 32 Product Technical Specialists and dedicated clinical experts who are not just […]
Anette Sjögren
Anette has over 30 years of experience from medical device and pharma industry as QA, RA, QP and the tasks within the medical fields such as quality and risk management, clinical affairs, toxicology and biocompatibility. Anette is a member of the Swedish (TK355) and the international Technical (TC210) committees since 2010. Since 2003 Anette is […]
Lena Baard
Lena Baard, the founder and proprietor of Florian Consulting AB, boasts over a decade of experience working with sterile medical devices. With a rich work-life background spanning more than 20 years in the Life Science industry, she has gained extensive expertise in both pharmaceutical manufacturing and Medical Device Manufacturing companies. Lena possesses specialized knowledge in […]
Anna Sahlholm
Anna Sahlholm is employed at GBA Key2Compliance and has more than 15 years of experience from product and process development in close collaboration with research and within the medical device industry. Anna has worked with research, product development, strategic product management, clinical evaluations, processes for traceability, risk management, quality, and regulatory compliance for a variety […]
Susanne Grimsby
Susanne Grimsby is employed at GBA Key2Compliance as a senior consultant in the Regulatory Affairs team. Susanne has more than 30 years of experience from the Life Science business of which the last 8 years in the medical device industry. Susanne has holds positions as QA/RA Manager and QA/RA consultant and has also acting in […]
Gustav Sundström
Gustav Sundström works as a regulatory consultant at GBA Key2Compliance AB since February 2022. He has more than 14 years of experience from electrical safety testing of medical equipment and laboratory equipment at Intertek Semko. Gustav now works with technical documentation for medical devices and helps clients with electrical safety. Gustav is a member of SEK […]
Anna-Karin Andermo
Anna-Karin Andermo is a senior regulatory affairs consultant at GBA Key2Compliance AB. She has worked at several small to medium sized medical device companies, both as a consultant and as a QA/RA manager. As a Regulatory Affairs manager at a medical device manufacturing company with products sold worldwide, Anna-Karin was responsible for the regulatory compliance […]
Hans Andersen
Hans has more than 40 years of experience in medical device technology. The last 25 years Hans has been focused on effective methods in demonstrating compliance with legal requirements related to medical devices. Hans has participated as Swedish expert in global standardisation committees as ISO/TC 210 IEC/SC 62A JWG1 that prepared the ISO 14971: Medical […]
Cyrille Michaud
Based in Aix-En-Provence (France), Mr. Michaud is a seasoned information technology engineer with experience in both software and Quality Affairs/Regulatory Affairs. Prior to his current position, he was Project Director from 2009 to 2011 at Olea Medical – a medical imaging start-up. His main achievements were the ISO 13485 certification and the CE Mark and […]