Management of Clinical Trials – Medical Devices

• Understand the regulatory and legal aspects of new Swiss and EU regulations governing medical devices, including Swiss Federal Medical Ordinance (MDO), Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), including certifications and submissions to competent bodies and authorities.
• Learn about the qualification and classification of medical devices under the new regulations.
• Gain knowledge of clinical investigation requirements and the process of submitting clinical trial applications to regulatory authorities.
• Develop strategies for market access, including navigating regulatory pathways and obtaining necessary approvals.
• Familiarise with conformity assessment procedures and the CE marking process for medical devices.
• Understand the principles and practices of materiovigilance for monitoring and reporting adverse events related to medical devices.
• Explore the role of digital health and medical software in the context of medical device regulation.
• Learn about combination products and the regulatory considerations involved in their development and approval.

• Ability to interpret and apply EU regulations (MDR, IVDR) to medical device development and management.
• Ability to classify medical devices according to regulatory requirements.
• Competence in planning and conducting clinical investigations and preparing clinical trial applications for regulatory submission.
• Skill in developing market access strategies and obtaining regulatory approvals for medical devices.
• Proficiency in conducting conformity assessments and ensuring compliance with CE marking requirements.
• Understanding of materiovigilance principles and practices for ensuring the safety of medical devices.
• Knowledge of digital health technologies and their regulatory implications in the medical device industry.
• Ability to navigate regulatory requirements for combination products and ensure compliance throughout the development process.

CHF 1,400

a) Holders of a university master's degree or doctorate in science, medicine or pharmacy or a qualification deemed equivalent;
or a bachelor's degree in nursing from a Swiss University of Applied Sciences;
or a qualification deemed equivalent or professional experience deemed equivalent by the programme directors.

b) Good oral and written comprehension of English (equivalent to level B2-C1)

• Copy of identity document
• Curriculum Vitae
• Copies of relevant university degrees
• Covering letter

• Andrea Lopes, Confinis AG
• Corinne Lebourgeois, MedC. Partners
• Fabiana Tirone, Clinical Trial Materio/Phamacovigilance Vigilance, HUG
• Didier Falconnet, Medical Devices & IVD Product Development expert
• Gabriel Avigdor, Attorney-at-law & Legal Director
• Markus Angst, Regulatory and tech consultant, ISS AG
• Mariagrazia Di Marco, Regulatory affairs specialist, CTU, HUG
• Marie Gaumet, Managing Director, SwAPP
• Rima Padovani, Director, Quality & Regulatory Affairs