Date:
June 10–14, 2024
Location:
DoubleTree by Hilton, Brussels City, Belgium
Or hybrid participation
Click here to register.
Abstract
Save time, effort, and money while ensuring compliance with global regulations and collaborating with the European Commission, notified bodies, competent authorities, working groups, and manufacturers.
Gain comprehensive insights into the manufacturing of medical devices and IVDs. Over the course of five days, the following eight topics will be explored and covered:
- Legal and Regulatory Compliance for Medical Devices
- European Regulations on Medical Devices
- In Vitro Diagnostic Regulations
- Biocompatibility for Medical Devices
- Regulatory Issues in Global Markets
- Clinical Assessments and Examinations & Performance Evaluations & PMS and Vigilance
- Software and AI for Medical Devices and IVDs
- Training Course: Project Management in Medical Technology
Learn more about the event here.
Take Part in Our Presentation
Thursday, June 13, 2024, 4:45 p.m. – 5:15 p.m.
Software and AI for Medical Devices and IVDs
From Algorithms to Approvals: Demystifying AI/ML Device Approval
- What are the key factors to consider when submitting an AI/ML device?
- Transparency regarding AI/ML performance and the data used to train and validate the model.
- Use of the best available methods for the reference dataset
- Ensuring generalizability to the intended patient population
- Considerations Regarding the Monitoring of AI/ML Performance After Market Launch and Regulatory Oversight
Our Speaker:
Richie Christian
He moved from New Zealand to Switzerland to work as a consultant for wega Informatik, where he now draws on his decades of experience to help companies develop and deliver compliant software for medical devices.
Richie has more than 10 years of experience in medical device regulation and quality assurance. He holds a master’s degree in neurophysiology from the University of Auckland and is passionately committed to the digital transformation of the healthcare industry.
Throughout his career, Richie has held numerous regulatory and quality assurance roles, not only at traditional hardware manufacturers but also at innovative AI/ML-enabled SaMD manufacturers.
For us here on site:
Christophe Girardey
Managing Director and Head of the CSV & QA Department at wega Informatik AG.
He works as a CSV consulting expert on many different projects, primarily in German-speaking countries.
He places a special focus on laboratory data systems (LIMS, chromatography data systems, Laboratory Execution System) and helps customers implement the best solution from various perspectives (efficiency, compliance, data integrity).
In addition, he helps many clients make the most of agile methodologies in a GxP environment.
Marc Assmann
Marc is an experienced CSV and quality management consultant at wega, with over 8 years of experience in GxP- and ISO 13485-regulated environments.
He holds a Ph.D. in Molecular Cell Biology and Bioinformatics and is a Certified Professional in Requirements Engineering, Testing, Medical Software, and Scrum Mastery.
Marc's expertise lies in quality assurance, data integrity, and the validation of computer systems, including eQMS, eDMS, LIMS, ELN, and data science platforms.
His unique combination of scientific knowledge and quality management skills enables him to deliver exceptional solutions that ensure regulatory compliance while promoting operational excellence.