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 EU Commission, notified bodies, competent authorities, working groups and manufacturers.
Gain comprehensive insights into the manufacture of medical devices and IVDs. During the five days, the following eight topics will be looked at and dealt with:
- Legal and regulatory compliance for medical devices
- European regulations for medical devices
- In vitro diagnostics regulations
- Biocompatibility for medical devices
- Regulatory matters in global markets
- Clinical assessments and examinations & performance assessments & 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 16:45 - 17:15
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 in terms of AI/ML performance and the data used to train/validate the model.
- Use of the best available methods for the reference data set
- Ensuring generalizability for the intended patient population
- Considerations for post-market monitoring of AI/ML performance and regulatory oversight
Our Speaker:
Richie Christian
He moved from New Zealand to Switzerland as a consultant for wega Informatik, where he now uses his decades of experience to support companies in the development and provision of compliant software for medical devices.
Richie has over 10 years' experience in medical device regulation and quality. He holds a Master's degree in Neurophysiology from the University of Auckland and is passionate about the digital transformation of the healthcare industry.
Throughout his career, Richie has served in numerous regulatory and quality roles, not only with traditional hardware manufacturers, but also with innovative AI/ML-enabled SaMD manufacturers.
For us on site:
Christophe Girardey
Managing Director and Head of the CSV & QA department at wega Informatik AG.
He works as a CSV consulting expert in many different projects, mainly in German-speaking countries.
He has a particular focus on laboratory data systems (LIMS, chromatography data systems, laboratory execution systems) and supports customers in implementing the best solution from various perspectives (efficiency, compliance, data integrity).
He also supports many customers in the optimal use of the agile methodology in the GxP environment.
Marc Assmann
Marc is an experienced CSV and quality management consultant at wega, with over 8 years experience in GxP and ISO 13485 regulated environments.
He holds a PhD 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 validation of computerized systems, including eQMS, eDMS, LIMS, ELN and data science platforms.
His unique blend of scientific knowledge and quality management skills enables him to deliver exceptional solutions that meet regulatory compliance while promoting operational excellence.