Andrea Biasiucci, Phd work email
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Andrea Biasiucci, Phd personal email
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I am a seasoned electronic and biomedical engineer with a PhD in Brain-Machine Interfaces from the Swiss Federal Institute of Technology Lausanne (EPFL). I currently work as CEO of confinis ag, one of the leading Swiss regulatory consulting firms specializing in medical devices, IVD, and combination products. I consider myself a business strategist that has deep knowledge of regulatory, quality and clinical affairs. I have extensive experience in agile transformation and organizational restructuring, with a proven track record in driving operational efficiency and innovation. I founded two neurotech startups: Intento SA, acquired by MindMaze Group in 2018, and braincredible SA, acquired by ANT Neuro in 2023, both pioneering advances in medical devices, AI and big data for healthcare.In my previous role at Roche, I served as the Global Evidence Operations Lead for Digital Solutions, where I led initiatives to integrate digital innovations into regulated healthcare environments.I believe in selfless leadership, and I promote whenever I can collaboration that empowers teams to achieve collective success.
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Integration LeaderAthagoras GroupBasel, Bs, Ch
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Chief Executive OfficerConfinis Jul 2023 - PresentDüdingen, Switzerland/Usa/Uk, Chconfinis is a global consulting firm in the field of medical devices, in vitro diagnostics and combination products based in Switzerland and the USA.Our range of services includes regulatory affairs, quality management, design control, risk management, usability engineering/human factors, clinical evaluation, labelling, manufacturing, process validation, supply chain, post-market monitoring, auditing, and training. -
Global Evidence Operations LeadRoche Jul 2022 - Jun 2023Switzerland 🇨🇭 , ChRoche Information Solutions, an organization of Roche Diagnostics, has the mission to develop digital products that positively impact and transform the life of patients worldwide. In this role, I was the global lead on Evidence Operations. Among my tasks, I ensured that regulated and non regulated digital solutions had an adequate operational support in the context of evidence generation. I have been responsible for the development of large structures operational models to support these new technologies, in collaboration with multiple internal stakeholders. Being at Roche allowed me to develop my leadership skills, develop a new view on big corporate agility, increase my knowledge of agile facilitation and transformation and put in practice my strategic experience in regulatory / quality / clinical affairs. -
FounderBraincredible Sa Sep 2019 - Mar 2023braincredible is a neurotech start-up company whose goal is to remove any barrier to the exploitation of big brain data. To this aim, the company provides neuroscience-as-a-service to create new neurotechnologies, collect big EEG data and build brain models for Artificial Intelligence and Machine Learning approaches.braincredible is a spin-off of ANT Neuro, one of world's leading EEG harware manufacters. -
Chief Executive OfficerBraincredible Sa Sep 2019 - Jun 2022
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Competence Cluster Lead, Head Of Digital HealthConfinis Jul 2020 - Jun 2022Düdingen, Switzerland/Usa/Uk, ChIn this role, I assisted companies in worldwide registrations of Digital Health projects- Regulatory strategy and interactions with Competent Authorities and Notified Bodies- Corporate Liaison / Innovative Patient Support Programs- Automated diagnostics, advanced robotics, neurotechnology - Validation QMS / eQMS automations based on AI and Machine Learning- Cybersecurity and data protectionAs a competence cluster lead, I built teams to serve current and future clients with questions on Clinical Evaluation (MDR, MEDDEV 2.7/1 rev.4, international registrations), Software Technical Documentation (IEC 62304/82304), and on electronic Quality Management Systems (including electronic records and electronic signatures).
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Senior ConsultantConfinis Jan 2019 - Jun 2020Düdingen, Switzerland/Usa/Uk, Ch- Responsible of Clinical Evaluation MDR, MEDDEV guidance 2.7/1 rev.4- MDR Transition, PMS/PMCF strategy - Electronic Paperless Quality Management Systems FDA 21 CFR Part 11, ISO 13485- Computer Software Validation and Software Life-cycle IEC 62304- Digital Health, (Active) Implantable Class III devices, Combination Products
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ConsultantConfinis Jul 2017 - Jan 2019Düdingen, Switzerland/Usa/Uk, ChRegulatory - EU MDR 2017/745 & MDD 93/42/EEC- ISO 13485:2016, FDA 21 CFR Part 820 - Drug/Device Combination ProductsClinical - Clinical Evaluation / Investigation, MEDDEV 2.7/1 rev. 4, ISO 14155- Clinical Research & Ethical Clearance - Biostatistics & Data AnalysisQuality - Electronic Quality Management Systems, FDA 21 CFR Part 11- Risk management, ISO 14971- Usability Engineering and Human Factors, IEC 62366
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Founder, Chief Clinical And Regulatory OfficerIntento Sa Jul 2012 - Jun 2018Lausanne, Vaud, ChIntento is a start-up company founded in 2016 from the Swiss Federal Institute of Technology in Lausanne, Switzerland (EPFL) and acquired in July 2018 by the MindMaze group.Intento helps people to move again through neuromuscular stimulation.The company strives to build simple, evidence-based solutions that have the potential to significantly improve the rehabilitation process and empower therapists to deliver more effective care.
Andrea Biasiucci, Phd Skills
Andrea Biasiucci, Phd Education Details
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EpflBrain-Computer Interfaces -
EpflHuman-Computer Interaction
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Università Degli Studi Di GenovaBiomedical Engineering
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University Of Bergen (Uib)Electronic Engineering
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Università Degli Studi Roma TreElectronic Engineering
Frequently Asked Questions about Andrea Biasiucci, Phd
What company does Andrea Biasiucci, Phd work for?
Andrea Biasiucci, Phd works for Athagoras Group
What is Andrea Biasiucci, Phd's role at the current company?
Andrea Biasiucci, Phd's current role is Integration Leader.
What is Andrea Biasiucci, Phd's email address?
Andrea Biasiucci, Phd's email address is an****@****ail.com
What schools did Andrea Biasiucci, Phd attend?
Andrea Biasiucci, Phd attended Epfl, Epfl, Università Degli Studi Di Genova, University Of Bergen (Uib), Università Degli Studi Roma Tre.
What are some of Andrea Biasiucci, Phd's interests?
Andrea Biasiucci, Phd has interest in Travelling, Snowboarding, Guitar And Bass Playing, Acoustic Instruments, Photography, Innovation And Good Food, Great Ideas, Good Food.
What skills is Andrea Biasiucci, Phd known for?
Andrea Biasiucci, Phd has skills like Signal Processing, Machine Learning, Matlab, Data Analysis, Biomedical Engineering, Eeg, Mathematical Modeling, Rehabilitation, Research, Statistics, Neuroimaging, Neural Interfaces.
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