Anna Sahlholm

Anna Sahlholm

Anna Sahlholm is employed at 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 of products. Anna’s […]

Susanne Grimsby

Susanne Grimsby

Susanne Grimsby is employed at 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 roles […]

Gustav Sundström

Gustav Sundström works as a regulatory consultant at 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 TK66, […]

Marcus Mellin

Marcus Mellin is a regulatory consultant at Key2Compliance AB since early 2021. He has previously more than 7 years of experience from the medical electrical safety testing industry at Intertek Semko, both as test engineer and as manager of the medical testing laboratory. Marcus specializes in risk management of medical devices and IVDs, as well […]

Anna-Karin Andermo

Anna-Karin Andermo

Anna-Karin Andermo is a senior regulatory affairs consultant at 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 of […]

Annette Hillring

Anette has been an independent regulatory affairs consultant since 1998. Prior to consulting, she was Director, Regulatory Affairs, for Critikon, a Johnson & Johnson Company, where she worked with cardiovascular monitoring devices since 1987. She has over 20 years’ experience in regulatory affairs, compliance and clinical affairs with prior experiences in the implantable cardiovascular and […]

Helena Dahlin

Helena Dahlin is working as a consultant at Key2Compliance® and has a broad experience from working in an international environment. Helena has an extensive knowledge about Medical Devices and the Post market process, and the need for a thorough Quality process. She is well experienced on the Medical Device industry on such as ISO 13485, […]

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 […]