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 […]

Simon Sjöhage

Simon Sjöhage is a quality and regulatory consultant at Key2Compliance®. Simon has a MSc in in Engineering and a bachelor- and master’s degree in medical engineering. He has experience as QA-manager at class I and II product manufacturing and research companies. QA-officer at manufacturing factory of class III product, ISO 13485, product release, non-conformities, CAPA […]

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 […]