Seb Clerkin
To be completed.
Oscar He
Oscar He is a Senior Advisor and certified auditor with extensive experience supporting medical device and health software companies across the full product lifecycle. He works with quality management systems, audits, technical documentation, and regulatory interactions, translating complex requirements into practical, business‑ready solutions. Oscar holds an MSc in Medical Biotechnology from KTH Royal Institute of […]
Joanna Jackson
With more than 20 years in medical device Quality and Regulatory, including 10 years in Regulatory Affairs, Joanna Jackson has extensive hands‑on experience guiding companies through compliance challenges and global regulatory pathways without losing sight of the business perspective. She is passionate about making regulatory requirements practical and accessible as well as providing coaching to […]
Claudia Dannehl
Based in Berlin, Claudia Dannehl is a scientist with a background in Physics and Biophysics and over a decade of experience in the medical device industry. As a versatile QA/RA and Clinical Generalist, she combines collaboration, creativity, and pragmatism to develop smart, actionable solutions that help teams confidently navigate European regulatory and clinical landscapes. Claudia […]
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 is one of our senior consultants, dedicated to supporting medical device and in vitro diagnostic (IVD) companies through a wide range of projects and training programs. She has a solid background from research and the life science business and with over 10 years of hands-on experience in QA/RA along, she brings a unique blend of technical expertise and practical insight to every project. Throughout her career, […]
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 […]