Upcoming trainings
Sprin 2025
ISO 13485 Standard Internal Auditing
Time: 18/03 and 29/04/2025 from 9 AM to 4 PM (EET)
Place: Online
Price: 690€ + VAT 25.5%
Topics of this session
Training Day 1
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Training Day 2
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Trainers

”I’m an experienced regulatory affairs and quality assurance professional who has worked for a number of Medical Device manufacturers, ranging from biodegradable orthopaedic implants to medical software for the US, EU and many other markets. I hold experience from senior managerial roles in multinational regulatory and quality-related positions and I have supported many Medical Device manufacturers and other economic operators as a regulatory consultant throughout my career that spans two decades.”
Target group
Professionals working with healthcare devices and supplies; quality managers; those responsible for developing and maintaining the quality management system or interested in these topics. Basic knowledge of the ISO 13485:2016 standard is required to participate.After this session, you
- You will have fundamental knowledge of the concept, scope, and procedures of auditing
- You will understand the significance of auditing as a tool for developing quality management
- You will gain the skills to function as an internal auditor in compliance with ISO 13485:2016 requirements
- You will know how to incorporate additional quality system requirements imposed by EU legislation (MDR 2017/745, IVDR 2017/746) into internal audits
- You will understand the special characteristics of auditing subcontractors
Notice
- The training is conducted in two parts.
- The intermediate assignment involves conducting an audit exercise in your own organization.
- Basic knowledge of the ISO 13485:2016 standard is required to participate in the training.
- The training includes small-group discussions and interactive exercises using various tools (e.g., Socrative, Kahoot, Mentimeter).