Amy Chan is a Product Reviewer in Cardiology at GMED North America. She has a Bachelor’s degree and Master’s degree in Bioengineering from University of California, San Diego. With over 15 years in pharmaceutical and medical device industries, she’s held R&D, manufacturing, and quality engineering roles at different medical device companies as well as product reviewer role for non-active cardiovascular devices at another notified body. Currently, she is responsible for performing the review of the Main and Biological Evaluation parts of the technical documentation and conducting training on MDR Technical Documentation and Risk Management

Pascal Bisson is a Product Reviewer & Lead Auditor at GMED. With extensive experience covering active devices and software, Pascal’s specialties include AI/ML in medical devices, cybersecurity, and software life-cycle processes. He supports manufacturers through CE Marking, quality system audits, and conformity assessments, and frequently contributes training on evolving regulatory expectations for MDSAP. He is also a Subject Matter Expert for MDSAP

Christopher Brodrick is a Senior Product Reviewer and Orthopedic Devices SME at GMED NA. He has a Master’s Degree in Biomedical Engineering from the University of Virginia, as well as a Bachelor’s Degree in Materials Engineering from Virginia Tech. With over 20 years of experience with CE Marking and medical devices, his past roles have included Clinical Affairs Manager at another notified body, Senior Consultant within a large CE Mark consulting company, and R&D Engineer within the medical device industry. Chris also has broad expertise in the area of Clinical Evaluation and PMCF for CE Marking and is a frequent speaker and trainer on these topics

Damien Barles is a Project Manager for Medical Devices – Artificial Intelligence at GMED (Paris). He leads AI/ML initiatives to adapt the GMED process to the AI Act requirements and works on regulatory strategy and conformity assessment for AI-enabled devices. With an engineering degree and a master’s degree in medical imaging data processing, he started his career with 10 years in a total artificial heart company, developing solutions to assess anatomical compatibility

Fatimazahra Meskini is a Certification Manager and experienced Lead Auditor at GMED. She is a Biomedical Engineer by training and has extensive expertise in auditing and regulatory compliance for medical devices. With a strong background in quality management systems and conformity assessment, Fatimazahra supports manufacturers in achieving CE Marking and maintaining compliance under the EU MDR