Düdingen, 03.07.2023 – confinis ag, a global consulting firm specializing in medical devices, in vitro diagnostics, and combination products, announces the appointment of Dr. Andrea Biasiucci as its new CEO, effective today, July 3rd, 2023. In this role, Andrea will lead the operational direction of confinis. Beat U. Steffen, the founder and current CEO, will transition to the position of Chairman of the Board of Directors (BoD) and Principal Consultant. These changes in the management structure align with the commitment of confinis to excellence and growth in the regulatory consulting industry in Switzerland and worldwide.

After 18 years in the role of CEO, confinis founder Beat U. Steffen transitions into the role of Chairman of the Board, where he will continue to play a pivotal role in the strategic, governance and decision-making processes at confinis. Additionally, Beat will continue to serve clients as the Principal Consultant, bringing nearly three decades of experience in complex and challenging regulatory cases to the medtech industry.

As the new CEO, Dr. Andrea Biasiucci will be responsible for the strategic and operational direction of confinis, for driving innovation, expanding the company’s services and for strengthening its global presence. His leadership skills and deep industry knowledge will fuel the company’s growth in the rapidly evolving consulting industry with a focus on deep tech and regulated innovation. Andrea is an electronic and biomedical engineer with a PhD in Brain-Machine Interfaces from the Swiss Federal Institute of Technology Lausanne (EPFL) and more than 10 years of experience in medical device innovation and digital health. In the past, Andrea created and sold two neurotech startup companies in Switzerland, before joining the digital products global evidence generation team at Roche in Basel. Andrea served at confinis for 5 years as Head of Digital Health, building and managing two teams of consultants specialized in the Clinical Evaluation of devices for market entry – including deep tech solutions – and in Medical Software, Machine Learning and AI.

“We are thrilled to welcome back Dr. Andrea Biasiucci to the confinis family as our new CEO,” said Beat, Chairman of the Board of Directors at confinis. “Andrea’s extensive leadership experience and entrepreneurial mindset make him the ideal candidate to guide our company through its next phase of growth. I look forward to collaborating closely with him as we continue to deliver exceptional results to our clients worldwide.”

Dr. Andrea Biasiucci expressed his excitement about his new role in confinis and the opportunities that lie ahead: “confinis has established itself as a trusted partner to companies facing complex global regulatory challenges. Never in history regulatory, quality and clinical affairs have played such a central role in the industry. I am honored to lead this remarkable family-owned business that over the years was able to build an extraordinary track record of success and talent pool of professionals. I know and love confinis and I will do all my best to build upon the impressive legacy that Beat and the whole confinis team have created. Together, we will continue to deliver added-value to our clients, empower our talented employees, and drive innovation within the industry.”

confinis is confident that this change in management structure will further strengthen its position as the leading Swiss regulatory consulting firm worldwide. As reflected in its motto, the company remains committed to its clients ensuring regulatory compliance and beyond.

For further information, please contact:

Sabrina Campana
Head of Communication
+41 78 797 2099

Download the press release in pdf here

About confinis:

confinis is a globally recognized consulting firm specializing in the field of medical devices, in vitro diagnostics, and combination products. With headquarters in Switzerland and a presence in the USA, confinis provides comprehensive and tailored solutions to meet the unique regulatory and quality challenges faced by organizations operating in these industries.