Archives: Speakers

Anna has more than 5 years experience in Clinical Investigations with Medical Device and over 8 years with Notified Body Certification of Medical Device Manufacturer.

Shauna is a versatile QM/RA professional, with extensive experience in project management, supporting research and development, developing clinical evaluations and associated documentation, facilitating new product introduction, optimising manufacturing operations, obtaining market access, and leading post-market surveillance activities. A validation subject matter expert with 10 years of hands-on validation experience, decision-making and a Major in Process Validation.

Carine Cochereau holds a Pharmacist PHD and a MBA in Industry management. Further to 3 years of pharmaceutical and clinical activities in hospitals located in Paris, Carine started her professional career in medical device industries within Johnson & Johnson for a period of 12 years followed by 2 years within Cardinal Health and Biom’up playing different roles in Quality, Regulatory and Clinical affairs activities. Since October of 2019, Carine has been part of Integra LifeSciences as VP International Regulatory Affairs.

Stefan Meyer is co-founder and CTO of Implandata Ophthalmic Products GmbH. He has more than fifteen years of experience in development of novel medical products meeting regulatory standards and market acceptance criteria.

He was co-founder of Cranium Telemetrics GmbH, a medical technology company with innovative neuro-surgery products whose technology was acquired 4 year after foundation by a leading US medical device company. Thereafter he was responsible for technology transfer to this company. Stefan Meyer was instrumental in developing Implandata Ophthalmic Products GmbH’s technology platform and utilizing this platform for products within medical applications. He is author of multiple medical technology patents.

Jie is focused on clinical evidence acquisition-oriented clinical trial organizations and medical affairs management. He provides medical expertise and support throughout product life-cycle, including medical strategy and requirements, clinical evaluation plan and report, HHE, risk analysis and mitigation, and post-market activities. Jie participated in MDR uplift project at the process and product level.

Experienced in medical & regulatory affairs consulting, familiar with Infusion, Transfusion, and Enteral Nutrition supporting devices, Advanced Hemodynamic Monitoring, orthopedic and dental implants, surgical navigation system, balloon catheter and stent, microscope, lens, and wound closure and healing covers.

Heinrich Martens, VP Regulatory Affairs, hasmore than 15 years of experience working in Regulatory Affairs / Medical Devices. In his carrier, Heinrich Martens, was leading and being responsible for the various Regulatory Affairs projects – e.g. implementation of the Medical Device Regulation, leading and building up RA teams.

Leading an international team, across the globe, and being in contact with Authorities, Notified Bodies and Regulators – is one of his key topics, within his current role.

Yvonne Leguil has 30 years of experience in planning, allocation, production and logistics. She has been part of major transformations including AI introductions in companies like Esprit, Puma, Hugo Boss, Orsay and Beeline.

Sanja Becirovic is a former Merchandiser and Business Development Manager for companies like Mango, Jigsaw and ASOS. Focusing on helping brands and retailers find their optimal price and expansion strategies with over 10 years of experience in the fashion industry.