Joachim Paap

Medical Device Q&R Compliance, Chemgineering Business Design GmbH Joachim Paap has more than 18 years of experience in the medical device industry in Quality, Regulatory & Compliance (product classes I to III). For many years he worked for internationally operating and leading medical device manufacturers as Q&R Manager (Quality Management Representative), Director Q&R Compliance, Q&R […]

Anna Lundén

Anna Lundén is training director and part owner in Key2Compliance AB. She works in close contact with the industry with both training and consultancy and has developed various training modules for many different levels of employees, from top management to line operators. She has long experience of working with European companies dealing with FDA requirements […]

Peter L. Knepell

Dr Pete Knepell is president of Peak Quality Services in Colorado Springs, CO. Since 1988 he has trained thousands of professionals in quality systems and quality improvement methodologies. His past clients include: several defence agencies, the Canadian Red Cross, Sony, Corning, Texas Instruments, Xerox, Hewlett Packard, Heritage Valley Health System, GlaxoSmithKline, Amgen, GE Healthcare, Roche […]

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 […]

Åse Ek

Åse Ek is employed at Key2Compliance® and has more than 20 years of experience in the Medical Device and Pharmaceutical industries. Åse has worked with product development, project management and quality and regulatory issues. In recent years, especially with QA / RA in post market surveillance and issues related to public procurement, marketing, and distribution. […]

Erika Egrelius

Erika Egrelius has been quality manager in medical device manufacturing and lab manager in Quality Control (Chemistry and Microbiology) for over 15 years. Erika is a qualified auditor and has training in industry-specific areas such as. ISO 13485, MDD and QSR (21 CFR 820). She has also completed University studies in Economics, Leadership and LEAN […]

Tomas Camnell

Tomas Camnell is working at Key2Compliance® and has 22 years of experience in QA / RA advice, consultation and training in medical technology and biotechnology. Tomas has 7 years’ experience as a Project Manager in the Life Science area. Tomas has experience and background as a line manager for international activities within Amersham Biosciences, responsible […]

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 […]